Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

This study has been terminated.
(Please see Detailed Description for termination reason.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00257192
First received: November 21, 2005
Last updated: December 2, 2011
Last verified: December 2011
Results First Received: March 23, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: placebo
Drug: Ziprasidone oral capsules

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A planned interim analysis resulted in recommendation from Data Safety Monitoring Board (DSMB) to terminate study due to futility per the interim analysis charter (p-value = 0.9840). Only one active subject in the study was affected by this decision.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening visit followed by a 1 to 10 day period to allow for wash-out of exclusionary medications.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Participant Flow:   Overall Study
    Ziprasidone     Placebo  
STARTED     193     91 [1]
Received Study Treatment     193     90  
COMPLETED     135     52  
NOT COMPLETED     58     39  
Adverse Event                 21                 10  
Laboratory abnormality                 1                 1  
Lost to Follow-up                 3                 3  
Insufficient clinical response                 18                 18  
Withdrawal by Subject                 14                 2  
Randomized but not treated                 0                 1  
Study terminated by sponsor                 1                 0  
Miscellaneous                 0                 4  
[1] Includes 1 subject randomized but not treated



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Total Total of all reporting groups

Baseline Measures
    Ziprasidone     Placebo     Total  
Number of Participants  
[units: participants]
  193     90     283  
Age, Customized  
[units: participants]
     
>12 years and <13 years at start of treatment     4     0     4  
Between 13 and 17 years     189     90     279  
Age  
[units: years]
Mean ± Standard Deviation
  15.3  ± 1.4     15.4  ± 1.4     15.3  ± 1.4  
Gender  
[units: participants]
     
Female     84     28     112  
Male     109     62     171  
Ethnicity  
[units: participants]
     
Hispanic / Latino     21     9     30  
Not Hispanic / Latino     172     81     253  
Race  
[units: particpants]
     
White     116     60     176  
Black     17     2     19  
Asian     38     17     55  
Hispanic     9     3     12  
Other     13     8     21  
Tanner adolescent pubertal self-assessment: Breast (females) [1]
[units: particpants]
     
Stage 1     0     1     1  
Stage 2     6     3     9  
Stage 3     16     4     20  
Stage 4     35     11     46  
Stage 5     25     9     34  
Not applicable     109     62     171  
Missing (not answered)     2     0     2  
Tanner adolescent pubertal self-assessment: Genitalia (males) [1]
[units: participants]
     
Stage 1     0     1     1  
Stage 2     9     3     12  
Stage 3     25     16     41  
Stage 4     57     26     83  
Stage 5     18     16     34  
Not applicable     82     28     110  
Missing (not answered)     2     0     2  
Tanner adolescent pubertal self-assessment: Pubic hair (females and males) [1]
[units: participants]
     
Stage 1     0     3     3  
Stage 2     13     7     20  
Stage 3     36     13     49  
Stage 4     90     43     133  
Stage 5     52     24     76  
Missing (not answered)     2     0     2  
Height  
[units: centimeters (cm)]
Mean ± Standard Deviation
  164.9  ± 10.1     167.8  ± 10.0     165.8  ± 10.1  
Weight  
[units: kilograms (kg)]
Mean ± Standard Deviation
  61.2  ± 15.5     64.3  ± 15.7     62.2  ± 15.6  
[1] At baseline, subjects self-administer a gender appropriate Tanner Adolescent Pubertal Staging Questionnaire to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; males pubertal development staged by size of the genitalia and development of pubic hair. Rated in 5 stages: stage 1 (no development) to 5 (adult-like development in quantity and size).



  Outcome Measures
  Hide All Outcome Measures

1.  Primary:   Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6   [ Time Frame: Baseline, Week 6 ]

Measure Type Primary
Measure Title Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6
Measure Description BPRS-A: 18-item clinician rated scale to assess somatic concern, anxiety, emotional withdrawal, disorganization, hallucinatory behavior, guilt feelings, suspiciousness, disorientation, tension, mannerisms, posturing, grandiosity, depressive mood, hostility, motor retardation, uncooperativeness, unusual thought content, blunted affect, and excitement. Ratings anchored to improve consistency for a single rater over time or between raters. Items rated on 7-point scale 0 (not present) to 6 (extremely severe). Total score=sum of items (range 0 to 108); higher scores indicate increased pathology.
Time Frame Baseline, Week 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat (ITT): all randomized subjects who had baseline measurements, took at least 1 dose of study medication, and had at least 1 post-baseline visit. N=number of subjects with analyzable data at post-baseline observation.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  189     87  
Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6  
[units: scores on a scale]
Least Squares Mean ± Standard Error
  -14.16  ± 0.78     -12.35  ± 1.05  


Statistical Analysis 1 for Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score at Week 6
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.1530
Least squares mean [4] -1.80
Standard Error of the mean ± 1.26
95% Confidence Interval ( -4.28 to 0.67 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Sample size for 85% power 2-tailed 0.05 significance level based on expected difference of -5 with average within-group standard deviation=13 was 276 subjects (2 to 1 ratio of enrollment: 184 ziprasidone, 92 placebo). Interim analysis at 60 percent (%) enrollment (ITT population): may stop trial early for efficacy (2-sided p-value less than (<) 0.0124) or for futility (2-sided p-value greater than (>) 0.4772; The final analysis is to employ a 2-sided p-value <0.0462.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  P-value for final analysis is to be adjusted due to planned interim analysis (0.0462).
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.
[4] Other relevant estimation information:
  No text entered.



2.  Secondary:   Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6   [ Time Frame: Baseline, Week 6 ]

Measure Type Secondary
Measure Title Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6
Measure Description CGI-S: single-item clinician rated scale to rate the severity of a subject's illness over time. Scores range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects); higher score indicates more affected.
Time Frame Baseline, Week 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; N=number of subjects with analyzable data at post-baseline observation.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  190     87  
Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6  
[units: scores on a scale]
Least Squares Mean ± Standard Error
  -1.05  ± 0.08     -0.84  ± 0.12  


Statistical Analysis 1 for Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Week 6
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.1289
Least squares mean [4] -0.21
Standard Error of the mean ± 0.14
95% Confidence Interval ( -0.48 to 0.06 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Difference from placebo
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.
[4] Other relevant estimation information:
  No text entered.



3.  Secondary:   Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6   [ Time Frame: Baseline, Week 6 ]

Measure Type Secondary
Measure Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6
Measure Description PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.
Time Frame Baseline, Week 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; N=number of subjects with analyzable data at post-baseline observation.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  183     86  
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6  
[units: scores on a scale]
Least Squares Mean ± Standard Error
  -23.58  ± 1.42     -21.01  ± 1.73  


Statistical Analysis 1 for Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Total Score at Week 6
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.1987
Least squares mean [4] -2.57
Standard Error of the mean ± 2.00
95% Confidence Interval ( -6.50 to 1.36 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Total score: difference from placebo
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Hochberg procedure was applied to p-value to preserve type I error in the analysis of key secondary endpoints (PANSS total score and CGI-S).
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects and baseline score as a covariate.
[4] Other relevant estimation information:
  No text entered.



4.  Secondary:   Change From Baseline in PANSS: Positive and Negative Subscales at Week 6   [ Time Frame: Baseline, Week 6 ]

Measure Type Secondary
Measure Title Change From Baseline in PANSS: Positive and Negative Subscales at Week 6
Measure Description PANSS: 30-item clinician-rated scale to measure severity of psychopathology (16 items); positive scale (7 items); negative scale (7 items); summarized as positive score, negative score, and total score. Items scored on anchored Likert scale rated 1 (absent symptoms) to 7 (extreme); scores above 1 indicate clinical symptom is present; scores from 2 to 7 indicate increased severity. Total score range 30 to 210: higher score indicates greater severity.
Time Frame Baseline, Week 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; N=number of subjects with analyzable data at post-baseline observation.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  183     86  
Change From Baseline in PANSS: Positive and Negative Subscales at Week 6  
[units: scores on a scale]
Least Squares Mean ± Standard Error
   
Positive score     -7.22  ± 0.44     -5.88  ± 0.56  
Negative score     -5.51  ± 0.43     -5.09  ± 0.51  


Statistical Analysis 1 for Change From Baseline in PANSS: Positive and Negative Subscales at Week 6
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.0412
Least squares mean [4] -1.33
Standard Error of the mean ± 0.65
95% Confidence Interval ( -2.61 to -0.05 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Positive score: difference from placebo
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Change From Baseline in PANSS: Positive and Negative Subscales at Week 6
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.4661
Least squares mean [4] -0.43
Standard Error of the mean ± 0.58
95% Confidence Interval ( -1.57 to 0.72 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Negative score: difference from placebo
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mixed effects repeated measures (MMRM) analysis of covariance model with subject as random effect, treatment, region, visit, and visit-by-treatment interaction as fixed effects and baseline score as a covariate.
[4] Other relevant estimation information:
  No text entered.



5.  Secondary:   Clinical Global Impression of Improvement (CGI-I) Score at Week 6   [ Time Frame: Baseline, Week 6 ]

Measure Type Secondary
Measure Title Clinical Global Impression of Improvement (CGI-I) Score at Week 6
Measure Description CGI-I: single-item clinician rated scale used to assess the subject's improvement or worsening from baseline. Scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse); higher score indicates more affected.
Time Frame Baseline, Week 6  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; N=number of subjects with analyzable data at post-baseline observation.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  190     87  
Clinical Global Impression of Improvement (CGI-I) Score at Week 6  
[units: scores on a scale]
Least Squares Mean ± Standard Error
  2.66  ± 0.09     2.85  ± 0.12  


Statistical Analysis 1 for Clinical Global Impression of Improvement (CGI-I) Score at Week 6
Groups [1] All groups
Method [2] ANOVA
P Value [3] 0.1820
Least squares mean [4] -0.19
Standard Error of the mean ± 0.14
95% Confidence Interval ( -0.47 to 0.09 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Difference from placebo
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  Mixed effects MMRM with subject as random effect, treatment, region, visit and visit-by-treatment interaction as fixed effects.
[4] Other relevant estimation information:
  No text entered.



6.  Secondary:   Change From Baseline in Children's Global Assessment Scale (CGAS)   [ Time Frame: Baseline, Week 2, Week 4, Week 6, Early termination (ET) ]

Measure Type Secondary
Measure Title Change From Baseline in Children's Global Assessment Scale (CGAS)
Measure Description CGAS: clinician-rated global assessment item for children based on symptoms and social functioning in home, school, and community settings. Scores on this single item range from 1 to 100 (higher levels indicate greater health) with descriptive anchors for every 10-point interval. Scores above 70 on this scale are considered within the “normal” range; lower score indicates need for increased supervision.
Time Frame Baseline, Week 2, Week 4, Week 6, Early termination (ET)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. Last observation carried forward [LOCF] imputation used for Week 6 LOCF timepoint.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  193     90  
Change From Baseline in Children's Global Assessment Scale (CGAS)  
[units: scores on a scale]
Mean ± Standard Deviation
   
Week 2 (n=183, 86)     4.7  ± 8.7     2.6  ± 5.8  
Week 4 (n=155, 63)     7.9  ± 10.4     6.2  ± 8.9  
Week 6 (n=135, 52)     10.9  ± 11.8     10.8  ± 9.9  
ET (n=20, 15)     1.3  ± 10.1     1.7  ± 8.9  
Week 6 [LOCF] (n=185, 87)     8.4  ± 11.8     6.4  ± 10.6  

No statistical analysis provided for Change From Baseline in Children's Global Assessment Scale (CGAS)



7.  Secondary:   Change From Baseline in Child Health Questionnaire (CHQ)   [ Time Frame: Baseline, Week 6, ET ]

Measure Type Secondary
Measure Title Change From Baseline in Child Health Questionnaire (CHQ)
Measure Description CHQ: 50-item, 15 subscale parent or legal guardian assessed instrument of child’s physical, emotional, social well-being, and relative burden of disease on the parents; rated on Likert-type scale: range 0 to 100; higher scores indicate a more positive health status. Global indicators for Physical Health and Psychosocial Health are weighted composites derived from subscale items using scoring algorithms (transformed scores); range 0 to 100: higher scores indicate more positive health status.
Time Frame Baseline, Week 6, ET  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  193     90  
Change From Baseline in Child Health Questionnaire (CHQ)  
[units: scores on a scale]
Mean ± Standard Deviation
   
Global health: Week 6     5.0  ± 18.2     8.5  ± 24.7  
Global health: ET     -5.4  ± 24.0     -9.1  ± 17.4  
Global health: Week 6 [LOCF]     2.8  ± 19.9     1.4  ± 23.7  
Global behavior: Week 6     9.4  ± 23.6     10.9  ± 22.1  
Global behavior: ET     6.4  ± 21.4     -0.5  ± 23.0  
Global behavior: Week 6 [LOCF]     8.8  ± 23.1     6.5  ± 23.1  
Family cohesion: Week 6     1.9  ± 21.3     -0.8  ± 19.7  
Family cohesion: ET     -1.8  ± 18.4     -2.6  ± 16.1  
Family cohesion: Week 6 [LOCF]     1.2  ± 20.8     -1.1  ± 18.1  
Physical health: Week 6     3.5  ± 33.9     5.0  ± 28.0  
Physical health: ET     -6.5  ± 32.9     3.2  ± 23.3  
Physical health: Week 6 [LOCF]     1.4  ± 33.8     4.8  ± 26.0  
Bodily pain: Week 6     4.4  ± 21.6     8.0  ± 19.4  
Bodily pain: ET     4.7  ± 23.0     0.0  ± 14.6  
Bodily pain: Week 6 [LOCF]     4.5  ± 21.9     4.9  ± 18.1  
Emotion, behavior: Week 6     16.2  ± 29.8     13.8  ± 31.1  
Emotion, behavior: ET     4.0  ± 43.1     -2.5  ± 22.7  
Emotion, behavior: Week 6 [LOCF]     13.6  ± 33.4     7.8  ± 29.2  
Time impact on parent: Week 6     8.8  ± 25.4     11.8  ± 23.1  
Time impact on parent: ET     2.0  ± 25.8     1.8  ± 21.7  
Time impact on parent: Week 6 [LOCF]     7.4  ± 25.5     8.0  ± 23.1  
Emotional impact on parent: Week 6     8.9  ± 21.6     10.0  ± 22.3  
Emotional impact on parent: ET     3.5  ± 21.2     2.7  ± 12.6  
Emotional impact on parent: Week 6 [LOCF]     7.7  ± 21.6     7.4  ± 19.4  
Mental health: Week 6     8.1  ± 15.3     12.6  ± 18.2  
Mental health: ET     1.3  ± 17.9     -0.8  ± 12.0  
Mental health: Week 6 [LOCF]     6.7  ± 16.1     7.5  ± 17.4  
Physical function: Week 6     5.6  ± 19.7     5.9  ± 25.2  
Physical function: ET     -5.4  ± 22.5     -0.2  ± 17.7  
Physical function: Week 6 [LOCF]     3.3  ± 20.8     3.7  ± 22.8  
Behavior scale: Week 6     9.0  ± 17.1     9.0  ± 16.8  
Behavior scale: ET     7.6  ± 15.2     0.6  ± 17.1  
Behavior scale: Week 6 [LOCF]     8.7  ± 16.7     5.8  ± 17.4  
Self-esteem: Week 6     6.0  ± 17.5     9.0  ± 22.9  
Self-esteem: ET     1.0  ± 20.6     1.3  ± 14.0  
Self-esteem: Week 6 [LOCF]     5.0  ± 18.2     6.4  ± 20.2  
General health perception: Week 6     1.1  ± 11.6     3.3  ± 11.7  
General health perception: ET     -2.2  ± 12.3     -0.6  ± 10.8  
General health perception: Week 6 [LOCF]     0.4  ± 11.8     1.8  ± 11.5  
Family activities: Week 6     9.2  ± 22.6     14.6  ± 22.5  
Family activities: ET     1.3  ± 16.8     -4.6  ± 16.5  
Family activities: Week 6 [LOCF]     7.5  ± 21.7     7.8  ± 22.0  
Change in health: Week 6     0.5  ± 1.1     0.6  ± 1.0  
Change in health: ET     -0.4  ± 1.0     -0.1  ± 0.8  
Change in health: Week 6 [LOCF]     0.3  ± 1.1     0.3  ± 1.0  
Physical health global subscale: Week 6     1.8  ± 9.7     2.4  ± 9.8  
Physical health global subscale: ET     -2.8  ± 11.8     0.1  ± 4.4  
Physical health global subscale: Week 6 [LOCF]     0.9  ± 10.3     1.6  ± 8.2  
Psychosocial health global subscale: Week 6     6.6  ± 9.5     7.7  ± 11.0  
Psychosocial health global subscale: ET     3.1  ± 10.4     0.0  ± 5.7  
Psychosocial health global subscale: Week 6 [LOCF]     5.9  ± 9.8     4.8  ± 10.0  

No statistical analysis provided for Change From Baseline in Child Health Questionnaire (CHQ)



8.  Secondary:   Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score   [ Time Frame: Baseline, Week 1 through Week 6 ]

Measure Type Secondary
Measure Title Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score
Measure Description CPBAQ: 19-item parent or legal guardian completed questionnaire to rate the child's verbal (such as yelling or cursing) and physical aggression (such a fighting with peers or being cruel to an animal) during the past week. Behavior was rated on a 4-point scale; range 0 (behavior did not occur or was not a problem) to 3 (behavior occurred a lot or was severe problem). Total score range 0 to 57; higher scores indicate a greater frequency and severity of aggression.
Time Frame Baseline, Week 1 through Week 6  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  173     74  
Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score  
[units: scores on a scale]
Mean ± Standard Deviation
   
Week 1 (n=165, 69)     -2.4  ± 7.1     -1.3  ± 5.8  
Week 2 (n=161, 71)     -2.5  ± 8.0     -1.0  ± 6.2  
Week 3 (n=146, 64)     -3.0  ± 6.7     -0.7  ± 5.7  
Week 4 (n=138, 51)     -2.7  ± 7.4     -1.0  ± 6.5  
Week 5 (n=126, 44)     -3.1  ± 7.0     -0.8  ± 8.3  
Week 6 (n=119, 42)     -3.0  ± 7.4     -1.9  ± 6.7  
Week 6 [LOCF] (n=167, 71)     -2.3  ± 8.2     -0.3  ± 8.8  

No statistical analysis provided for Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score



9.  Secondary:   Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score   [ Time Frame: Baseline, Week 1 through Week 6 ]

Measure Type Secondary
Measure Title Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
Measure Description CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment.
Time Frame Baseline, Week 1 through Week 6  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  180     84  
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score  
[units: scores on a scale]
Mean ± Standard Deviation
   
Week 1 (n=179, 82)     -2.8  ± 6.6     -1.4  ± 5.7  
Week 2 (n=174, 80)     -4.2  ± 7.3     -2.5  ± 5.6  
Week 3 (n=157, 69)     -5.5  ± 7.4     -3.2  ± 5.4  
Week 4 (n=148, 59)     -6.0  ± 7.6     -4.9  ± 6.6  
Week 5 (n=135, 49)     -7.0  ± 8.5     -5.6  ± 5.9  
Week 6 (n=126, 47)     -7.9  ± 7.9     -6.5  ± 5.5  
Week 6 [LOCF] (n=178, 82)     -5.8  ± 8.7     -4.0  ± 7.3  

No statistical analysis provided for Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score



10.  Secondary:   Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13   [ Time Frame: Baseline, Week 1 through Week 6 ]

Measure Type Secondary
Measure Title Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13
Measure Description CDRS-R: clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Suicide Ideation (Item 13) detects changes in suicidality over time. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).
Time Frame Baseline, Week 1 through Week 6  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  192     90  
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13  
[units: scores on a scale]
Mean ± Standard Deviation
   
Week 1 (n=188, 86)     -0.1  ± 0.4     -0.0  ± 0.5  
Week 2 (n=182, 86)     -0.0  ± 0.5     -0.1  ± 0.5  
Week 3 (n=165, 74)     -0.1  ± 0.5     -0.1  ± 0.3  
Week 4 (n=154, 63)     0.0  ± 0.5     -0.1  ± 0.5  
Week 5 (n=141, 54)     0.0  ± 0.4     -0.1  ± 0.5  
Week 6 (n=134, 52)     -0.0  ± 0.3     -0.1  ± 0.4  
Week 6 [LOCF] (n=189, 87)     0.0  ± 0.6     -0.0  ± 0.5  

No statistical analysis provided for Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Suicide Ideation Item 13



11.  Secondary:   Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1   [ Time Frame: Baseline, Week 2, Week 6 ]

Measure Type Secondary
Measure Title Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1
Measure Description Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses resolved by using most impaired rating given by valid informant. Impaired Schoolwork (Item 1) assesses school function for the subgroup of subjects reported to be in school. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment).
Time Frame Baseline, Week 2, Week 6  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  40     15  
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1  
[units: scores on a scale]
Mean ± Standard Deviation
   
Week 2 (n=38, 15)     -0.3  ± 0.9     -0.2  ± 0.7  
Week 6 (n=30, 8)     -0.6  ± 1.1     -0.1  ± 1.4  
Week 6 [LOCF] (n=39, 15)     -0.6  ± 1.0     -0.1  ± 1.1  

No statistical analysis provided for Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Impaired Schoolwork Item 1



12.  Secondary:   Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales   [ Time Frame: Baseline, Week 6, ET ]

Measure Type Secondary
Measure Title Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Measure Description A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject’s changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).
Time Frame Baseline, Week 6, ET  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint (last post-baseline non-missing visit).

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  174     83  
Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales  
[units: scores on a scale]
Mean ± Standard Deviation
   
Sedation: Week 6 (n=124, 47)     0.0  ± 1.7     -0.4  ± 1.8  
Sedation: ET (n=23, 26)     0.0  ± 2.3     0.2  ± 1.3  
Sedation: Week 6 [LOCF] (n=147, 72)     0.0  ± 1.8     -0.2  ± 1.7  
Verbal Memory: Week 6 (n=124, 47)     1.3  ± 12.1     0.5  ± 14.0  
Verbal Memory: ET (n=24, 25)     -2.3  ± 13.9     -2.6  ± 15.1  
Verbal Memory: Week 6 [LOCF] (n=148, 71)     0.7  ± 12.4     -0.5  ± 14.4  
Visual Memory: Week 6 (n=124, 46)     0.5  ± 13.3     2.0  ± 14.5  
Visual Memory: ET (n=24, 26)     -3.8  ± 10.2     0.4  ± 14.2  
Visual Memory: Week 6 [LOCF] (n=148, 71)     -0.2  ± 12.9     1.2  ± 14.3  
Processing Speed: Week 6 (n=124, 46)     1.3  ± 13.5     1.0  ± 12.0  
Processing Speed: ET (n=24, 25)     -10.6  ± 34.5     0.5  ± 5.4  
Processing Speed: Week 6 [LOCF] (n=148, 70)     -0.6  ± 18.9     0.6  ± 10.1  
Reasoning: Week 6 (n=122, 46)     2.2  ± 12.0     -0.7  ± 14.6  
Reasoning: ET (n=23, 25)     1.3  ± 15.8     3.3  ± 14.0  
Reasoning: Week 6 [LOCF] (n=145, 70)     1.9  ± 12.7     0.7  ± 14.1  
Executive Functioning: Week 6 (n=123, 46)     2.9  ± 15.4     2.7  ± 18.2  
Executive Functioning: ET (n=23, 26)     -6.7  ± 9.1     4.6  ± 13.2  
Executive Functioning: Week 6 [LOCF] (n=146, 71)     1.4  ± 14.9     3.2  ± 16.6  
Working Memory: Week 6 (n=120, 45)     1.9  ± 12.9     0.5  ± 12.9  
Working Memory: ET (n=23, 24)     3.2  ± 13.5     3.7  ± 11.0  
Working Memory: Week 6 [LOCF] (n=143, 68)     2.0  ± 12.9     1.3  ± 12.2  
Sustained Attention: Week 6 (n=120, 45)     2.0  ± 12.3     -1.6  ± 13.1  
Sustained Attention: ET (n=23, 24)     0.5  ± 13.5     1.5  ± 11.6  
Sustained Attention: Week 6 [LOCF] (n=143, 68)     1.7  ± 12.4     -0.9  ± 12.6  

No statistical analysis provided for Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales



13.  Secondary:   Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index   [ Time Frame: Baseline, Week 6, ET ]

Measure Type Secondary
Measure Title Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index
Measure Description A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject’s changes in cognition. Scores were rated as above average (score >109), average (90 to 109), below average (80 to 89), or well below average (70 to 79).
Time Frame Baseline, Week 6, ET  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint (last post-baseline non-missing visit).

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  168     79  
Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index  
[units: scores on a scale]
Mean ± Standard Deviation
   
Neurocognitive Index: Week 6 (n=120, 45)     1.8  ± 7.1     0.8  ± 7.5  
Neurocognitive Index: ET (n=23, 23)     -2.7  ± 7.6     2.2  ± 7.2  
Neurocognitive Index: Week 6 [LOCF] (n=143, 67)     1.0  ± 7.4     1.1  ± 7.4  


Statistical Analysis 1 for Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index
Groups [1] All groups
Method [2] ANCOVA
P Value [3] 0.2613
Least squares mean [4] 1.34
Standard Error of the mean ± 1.19
95% Confidence Interval ( -1.01 to 3.69 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Neurocognitive Index score at Week 6: difference from placebo
[2] Other relevant method information, such as adjustments or degrees of freedom:
  Observed cases at Week 6.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  SAS PROC MIXED to fit a mixed model analysis of covariance with treatment and region as fixed effects and baseline score as covariate.
[4] Other relevant estimation information:
  No text entered.



14.  Secondary:   Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS)   [ Time Frame: Baseline, Week 1 through Week 6 ]

Measure Type Secondary
Measure Title Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS)
Measure Description SARS: 10-item clinician rated instrument to assess parkinsonian symptoms (7 items) and related extrapyramidal side effects (3 items): gait, arm dropping, shoulder shaking, elbow rigidity, leg pendulousness, glabellar tap, tremor, and salivation. Head dropping (modified SARS item 7) substituted for head rotation. Anchored 5-point scale: range 0 (absence of condition, normal) to 4 (most extreme form of condition). Total score is sum of individual item scores (range 0 to 40); higher score indicates more affected.
Time Frame Baseline, Week 1 through Week 6  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  189     87  
Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS)  
[units: scores on a scale]
Mean ± Standard Deviation
   
Week 1 (n=189, 85)     0.5  ± 2.8     0.1  ± 0.9  
Week 2 (n=182, 85)     0.5  ± 2.4     -0.0  ± 0.5  
Week 3 (n=165, 74)     0.7  ± 3.1     0.3  ± 1.6  
Week 4 (n=154, 62)     0.4  ± 2.6     -0.0  ± 0.6  
Week 5 (n=141, 54)     0.2  ± 2.4     -0.0  ± 1.0  
Week 6 (n=134, 52)     0.2  ± 2.5     -0.2  ± 0.8  
Week 6 [LOCF] (n=189, 86)     0.3  ± 2.5     -0.1  ± 0.6  

No statistical analysis provided for Change From Baseline in Movement Disorder Scales: Simpson-Angus Rating Scale (SARS)



15.  Secondary:   Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item   [ Time Frame: Baseline, Week 1 through Week 6 ]

Measure Type Secondary
Measure Title Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
Measure Description BAS: clinician rated scale to assess akathisia to determine the degree of subjective restlessness and distress associated with restlessness. First 3 items (Objective, Subjective, and Distress related to restlessness) rated on a 4-point scale with range 0 (no symptoms) to 3 (increased severity of symptoms). Item 4 Global Clinical Assessment of Akathisia rated on a 6-point scale range 0 (no symptoms) to 5 (increased severity of symptoms); higher score indicates increased severity. All rating are anchored. Only the Global Clinical Assessment of Akathisia was to be analyzed.
Time Frame Baseline, Week 1 through Week 6  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; N=number of subjects with analyzable data at baseline; (n)= number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  190     88  
Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item  
[units: scores on a scale]
Mean ± Standard Deviation
   
Week 1 (n=190, 86)     0.1  ± 0.6     0.1  ± 0.4  
Week 2 (n=183, 86)     0.1  ± 0.7     0.0  ± 0.3  
Week 3 (n=166, 74)     0.1  ± 0.6     0.0  ± 0.3  
Week 4 (n=155, 63)     0.1  ± 0.6     -0.0  ± 0.2  
Week 5 (n=142, 54)     0.1  ± 0.5     0.0  ± 0.2  
Week 6 (n=135, 52)     0.0  ± 0.5     0.0  ± 0.2  
Week 6 [LOCF] (n=190, 87)     0.0  ± 0.6     0.0  ± 0.2  

No statistical analysis provided for Change From Baseline in Movement Disorder Scales: Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item



16.  Secondary:   Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score   [ Time Frame: Baseline, Week 1 through Week 6 ]

Measure Type Secondary
Measure Title Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
Measure Description AIMS: clinician rated 12-item scale to rate 7 body areas and global judgments on the severity of abnormal movements, incapacitation and subject's awareness of abnormal movements. Items 1 to 10 scored 0 (none) to 4 (severe) (total possible score 0 to 40; higher score indicates greater severity); items 11 to 14 are No or Yes response to dental status and sleep movements. Only the sum of the first 7 items to be analyzed (AIMS Movement Cluster score). Total score 0 to 28; higher score indicates greater severity.
Time Frame Baseline, Week 1 through Week 6  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; N=number of subjects with analyzable data at baseline; (n)=number of subjects with analyzable data at post-baseline observation for ziprasidone and placebo, respectively. LOCF imputation used for Week 6 LOCF timepoint.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  190     88  
Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score  
[units: scores on a scale]
Mean ± Standard Deviation
   
Week 1 (n=190, 86)     0.2  ± 1.6     -0.0  ± 0.4  
Week 2 (n=183, 86)     0.1  ± 1.6     0.0  ± 0.6  
Week 3 (n=166, 74)     0.1  ± 1.3     0.1  ± 1.0  
Week 4 (n=155, 63)     0.1  ± 0.8     -0.0  ± 0.8  
Week 5 (n=142, 54)     -0.1  ± 0.7     0.0  ± 0.4  
Week 6 (n=135, 52)     0.0  ± 0.6     0.0  ± 0.5  
Week 6 [LOCF] (n=190, 87)     0.0  ± 0.8     -0.0  ± 0.7  

No statistical analysis provided for Change From Baseline in Movement Disorder Scales: Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score



17.  Secondary:   Number of Subjects Per Response on the School Placement Questionnaire: School Situation   [ Time Frame: Baseline, Week 2, Week 6, ET ]

Measure Type Secondary
Measure Title Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Measure Description School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
Time Frame Baseline, Week 2, Week 6, ET  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  189     87  
Number of Subjects Per Response on the School Placement Questionnaire: School Situation  
[units: participants]
   
Baseline: Enrolled or attend (n=185, 85)     40     15  
Baseline: Not attend or mental illness (n=185, 85)     62     26  
Baseline: Not attend or other (n=185, 85)     2     0  
Baseline: Enrolled or vacation (n=185, 85)     20     19  
Baseline: Not enrolled or mental illness     36     12  
Baseline: Not enrolled or other (n=185, 85)     25     13  
Week 2: Enrolled or attend (n=179, 84)     38     20  
Week 2: Not attend or mental illness (n=179, 84)     59     24  
Week 2: Not attend or other (n=179, 84)     3     2  
Week 2: Enrolled or vacation (n=179, 84)     20     11  
Week 2: Not enrolled or mental illness (n=179, 84)     36     15  
Week 2: Not enrolled or other (n=179, 84)     23     12  
Week 6: Enrolled or attend (n=134, 51)     38     18  
Week 6: Not attend or mental illness (n=134, 51)     36     7  
Week 6: Not attend or other (n=134, 51)     3     0  
Week 6: Enrolled or vacation (n=134, 51)     14     5  
Week 6: Not enrolled or mental illness (n=134, 51)     23     11  
Week 6: Not enrolled or other (n=134, 51)     20     10  
ET: Enrolled or attend (n=32, 25)     5     3  
ET: Not attend or mental illness (n=32, 25)     8     14  
ET: Not attend or other (n=32, 25)     0     0  
ET: Enrolled or vacation (n=32, 25)     5     4  
ET: Not enrolled or mental illness (n=32, 25)     10     3  
ET: Not enrolled or other (n=32, 25)     4     1  
Week 6 [LOCF]: Enrolled or attend (n=183, 86)     47     23  
Week 6 [LOCF]: Not attend or mental illness     50     86  
Week 6 [LOCF]: Not attend or other (n=183, 86)     3     1  
Week 6 [LOCF]: Enrolled or vacation (n=183, 86)     21     10  
Week 6 [LOCF]: Not enrolled or mental illness     36     17  
Week 6 [LOCF]: Not enrolled or other (n=183, 86)     26     12  

No statistical analysis provided for Number of Subjects Per Response on the School Placement Questionnaire: School Situation



18.  Secondary:   Number of Subjects Per Response on the School Placement Questionnaire: School Attendance   [ Time Frame: Baseline, Week 2, Week 6, ET ]

Measure Type Secondary
Measure Title Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Measure Description School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
Time Frame Baseline, Week 2, Week 6, ET  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  189     87  
Number of Subjects Per Response on the School Placement Questionnaire: School Attendance  
[units: participants]
   
Baseline: No absences (n=88, 42)     20     7  
Baseline: Only a few absences (n=88, 42)     16     15  
Baseline: Frequent absences (n=88, 42)     13     2  
Baseline: Did not attend (n=88, 42)     26     7  
Baseline: Not applicable or vacation (n=88, 42)     13     11  
Week 2: No absences (n=82, 36)     19     8  
Week 2: Only a few absences (n=82, 36)     14     9  
Week 2: Frequent absences (n=82, 36)     11     4  
Week 2: Did not attend (n=82, 36)     25     8  
Week 2: Not applicable or vacation (n=82, 36)     13     7  
Week 6: No absences (n=67, 24)     16     8  
Week 6: Only a few absences (n=67, 24)     22     12  
Week 6: Frequent absences (n=67, 24)     5     0  
Week 6: Did not attend (n=67, 24)     13     0  
Week 6: Not applicable or vacation (n=67, 24)     11     4  
ET: No absences (n=12, 12)     1     0  
ET: Only a few absences (n=12, 12)     4     0  
ET: Frequent absences (n=12, 12)     2     5  
ET: Did not attend (n=12, 12)     4     4  
ET: Not applicable or vacation (n=12, 12)     1     3  
Week 6 [LOCF]: No absences (n=89, 37)     18     8  
Week 6 [LOCF]: Only a few absences (n=89, 37)     26     13  
Week 6 [LOCF]: Frequent absences (n=89, 37)     11     4  
Week 6 [LOCF]: Did not attend (n=89, 37)     21     4  
Week 6[LOCF]: Not applicable or vacation(n=89,37)     13     8  

No statistical analysis provided for Number of Subjects Per Response on the School Placement Questionnaire: School Attendance



19.  Secondary:   Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance   [ Time Frame: Baseline, Week 2, Week 6, ET ]

Measure Type Secondary
Measure Title Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Measure Description School placement questionnaire: parent or legal guardian assessed questionnaire to determine whether the child is currently enrolled in school (or planned to be enrolled if on school holiday like summer break), whether attending regularly if enrolled, and how well the child is doing overall in school. Questions were modified from those used in the National Institute of Mental Health (NIMH) funded Treatment of Early Onset Schizophrenia Spectrum (TEOSS) study. Results determine whether subjects are currently attending school and qualitatively describe how well they are doing in school.
Time Frame Baseline, Week 2, Week 6, ET  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT; N=number of subjects analyzable for School Placement Questionnaire; (n)=number of subjects with analyzable data at baseline and post-baseline observation for ziprasidone and placebo, respectively. ET includes observations from visits not within windowing criteria. LOCF imputation used for Week 6 LOCF timepoint.

Reporting Groups
  Description
Ziprasidone Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
Placebo Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.

Measured Values
    Ziprasidone     Placebo  
Number of Participants Analyzed  
[units: participants]
  189     87  
Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance  
[units: participants]
   
Baseline: Excellent (n=64, 29)     4     2  
Baseline: Good (n=64, 29)     10     6  
Baseline: Fair (n=64, 29)     25     14  
Baseline: Poor (n=64, 29)     19     3  
Baseline: Very poor (n=64, 29)     6     4  
Week 2: Excellent (n=60, 26)     5     1  
Week 2: Good (n=60, 26)     12     8  
Week 2: Fair (n=60, 26)     20     10  
Week 2: Poor (n=60, 26)     17     5  
Week 2: Very poor (n=60, 26)     6     2  
Week 6: Excellent (n=52, 21)     4     1  
Week 6: Good (n=52, 21)     16     8  
Week 6: Fair (n=52, 21)     17     11  
Week 6: Poor (n=52, 21)     12     1  
Week 6: Very poor (n=52, 21)     3     0  
ET: Excellent (n=8, 7)     0     0  
ET: Good (n=8, 7)     0     1  
ET: Fair (n=8, 7)     5     3  
ET: Poor (n=8, 7)     2     1  
ET: Very poor (n=8, 7)     1     2  
Week 6 [LOCF]: Excellent (n=68, 28)     4     1  
Week 6 [LOCF]: Good (n=68, 28)     18     9  
Week 6 [LOCF]: Fair (n=68, 28)     24     14  
Week 6 [LOCF]: Poor (n=68, 28)     16     2  
Week 6 [LOCF]: Very poor (n=68, 28)     6     2  

No statistical analysis provided for Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance




  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The AE tables were amended to incorporate previously unreported AEs that were found during an independent audit and verified by the investigators.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00257192     History of Changes
Other Study ID Numbers: A1281134
Study First Received: November 21, 2005
Results First Received: March 23, 2010
Last Updated: December 2, 2011
Health Authority: United States: Food and Drug Administration