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Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia

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ClinicalTrials.gov Identifier: NCT00265382
Recruitment Status : Terminated (Please see Detailed Description for termination reason.)
First Posted : December 14, 2005
Results First Posted : May 19, 2010
Last Update Posted : December 6, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Ziprasidone oral capsules
Enrollment 221
Recruitment Details This study enrolled adolescent subjects with schizophrenia, ages 13-17 years, who participated in the double-blind placebo controlled Study A1281134 (NCT00257192) who met qualification criteria and wished to receive treatment with open-label ziprasidone.
Pre-assignment Details  
Arm/Group Title Ziprasidone
Hide Arm/Group Description Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kilograms (kg). For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day [BID]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Period Title: Overall Study
Started 221
Completed 76
Not Completed 145
Reason Not Completed
Adverse Event             21
Laboratory Abnormality             1
Lost to Follow-up             3
Lack of Efficacy             6
Miscellaneous             6
Withdrawal by Subject             13
Study terminated by sponsor             94
Death             1
Arm/Group Title Ziprasidone
Hide Arm/Group Description Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Overall Number of Baseline Participants 221
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 221 participants
>12 years and <13 years at start of treatment 3
13 to 17 years 218
[1]
Measure Description: Baseline data are from the preceding Study A1281134 (NCT00257192).
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 221 participants
Female
90
  40.7%
Male
131
  59.3%
1.Primary Outcome
Title Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set = all subjects who took at least one dose of study medication. In this table, the number of subjects with AEs is based on a 0% AE threshold whereas the number of subjects with AEs reported in the AE section are based on a 5% AE threshold.
Arm/Group Title Ziprasidone
Hide Arm/Group Description:
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Overall Number of Participants Analyzed 221
Measure Type: Number
Unit of Measure: participants
AEs 137
SAEs 16
2.Secondary Outcome
Title Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment
Hide Description Tanner Adolescent Pubertal Staging Questionnaire: used 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).
Time Frame Baseline, Week 26, Early Termination (ET)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. N=number of subjects with analyzable data at baseline. Baseline data from Study A1281134 (NCT00257192) served as the baseline for A1281135.
Arm/Group Title Ziprasidone
Hide Arm/Group Description:
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Overall Number of Participants Analyzed 73
Measure Type: Number
Unit of Measure: participants
Pubic Hair, Week 26 (Stage 1) 1
Pubic Hair, Week 26 (Stage 2) 1
Pubic Hair, Week 26 (Stage 3) 11
Pubic Hair, Week 26 (Stage 4) 39
Pubic Hair, Week 26 (Stage 5) 21
Pubic Hair, ET (Stage 1) 0
Pubic Hair, ET (Stage 2) 10
Pubic Hair, ET (Stage 3) 22
Pubic Hair, ET (Stage 4) 59
Pubic Hair, ET (Stage 5) 30
3.Secondary Outcome
Title Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score
Hide 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, Weeks 2, 6, 18, 26, ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). Last Observation Carried Forward (LOCF) imputation used for Week 26 LOCF time point.
Arm/Group Title Ziprasidone
Hide Arm/Group Description:
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Overall Number of Participants Analyzed 208
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 2 (n=178) -0.3  (4.8)
Week 6 (n=153) -0.8  (6.1)
Week 18 (n=93) -0.5  (6.5)
Week 26 (n=68) 0.7  (7.7)
ET (n=113) 0.5  (7.1)
Week 26 LOCF (n=177) -0.5  (7.0)
4.Secondary Outcome
Title Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score
Hide 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, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
Arm/Group Title Ziprasidone
Hide Arm/Group Description:
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Overall Number of Participants Analyzed 214
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 (n=198) -1.4  (4.8)
Week 2 (n=188) -2.2  (6.1)
Week 6 (n=160) -3.5  (6.3)
Week 10 (n=129) -4.6  (7.3)
Week 14 (n=105) -5.0  (7.4)
Week 18 (n=94) -4.9  (8.1)
Week 22 (n=78) -5.1  (7.9)
Week 26 (n=72) -5.3  (7.8)
ET (n=122) -2.7  (7.3)
Week 26 LOCF (n=197) -4.5  (7.0)
5.Secondary Outcome
Title Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales
Hide Description Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. 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, Weeks 6 and 26, ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
Arm/Group Title Ziprasidone
Hide Arm/Group Description:
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Overall Number of Participants Analyzed 212
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Sedation: Week 6 (n=149) 0.1  (1.7)
Sedation: Week 26 (n=70) -0.2  (1.5)
Sedation: ET (n=102) -0.1  (2.0)
Sedation: Week 26 LOCF (n=153) -0.2  (1.7)
Verbal Memory: Week 6 (n=150) -1.3  (13.7)
Verbal Memory: Week 26 (n=71) 0.6  (14.0)
Verbal Memory: ET (n=103) -0.7  (14.6)
Verbal Memory: Week 26 LOCF (n=155) 0.3  (14.5)
Visual Memory: Week 6 (n=148) -3.6  (13.7)
Visual Memory: Week 26 (n=71) -2.1  (15.5)
Visual Memory: ET (n=103) -1.9  (12.7)
Visual Memory: Week 26 LOCF (n=154) -1.5  (14.4)
Processing Speed: Week 6 (n=148) -1.2  (11.4)
Processing Speed: Week 26 (n=71) 2.1  (10.2)
Processing Speed: ET (n=103) -1.4  (19.0)
Processing Speed: Week 26 LOCF (n=153) 0.5  (12.0)
Reasoning: Week 6 (n=145) -0.3  (14.1)
Reasoning: Week 26 (n=71) 3.0  (11.3)
Reasoning: ET (n=100) 1.9  (14.9)
Reasoning: Week 26 LOCF (n=151) 1.5  (14.3)
Executive Functioning: Week 6 (n=145) 2.0  (16.7)
Executive Functioning: Week 26 (n=71) 2.0  (16.8)
Executive Functioning: ET (n=100) 2.4  (15.7)
Executive Functioning: Week 26 LOCF (n=151) 2.4  (16.9)
Working Memory: Week 6 (n=145) -0.5  (12.6)
Working Memory: Week 26 (n=68) 0.8  (16.4)
Working Memory: ET (n=99) 0.3  (12.1)
Working Memory: Week 26 LOCF (n=150) 0.7  (14.2)
Sustained Attention: Week 6 (n=145) 0.2  (12.0)
Sustained Attention: Week 26 (n=68) 1.9  (14.0)
Sustained Attention: ET (n=99) -0.6  (12.2)
Sustained Attention: Week 26 LOCF (n=150) 1.2  (12.7)
6.Secondary Outcome
Title Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index
Hide Description Computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, sustained attention. Computerized 7- point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. Neurocognitive index score was derived from subtest scores per an algorithm. 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, Weeks 6 and 26, ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
Arm/Group Title Ziprasidone
Hide Arm/Group Description:
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Overall Number of Participants Analyzed 208
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Neurocognitive Index: Week 6 (n=144) -0.6  (7.2)
Neurocognitive Index: Week 26 (n=68) 1.3  (7.3)
Neurocognitive Index: ET (n=99) 0.5  (6.3)
Neurocognitive Index: Week 26 LOCF (n=150) 0.7  (7.7)
7.Secondary Outcome
Title Change From Baseline in Simpson-Angus Rating Scale (SARS)
Hide 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, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
Arm/Group Title Ziprasidone
Hide Arm/Group Description:
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Overall Number of Participants Analyzed 221
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 (n=206) -0.05  (1.4)
Week 2 (n=197) -0.11  (1.3)
Week 6 (n=168) -0.04  (1.7)
Week 10 (n=135) -0.10  (1.6)
Week 14 (n=110) -0.02  (1.9)
Week 18 (n=99) 0.02  (1.4)
Week 22 (n=82) -0.04  (1.7)
Week 26 (n=76) -0.32  (1.4)
ET (n=127) -0.31  (2.0)
Week 26 LOCF (n=206) -0.15  (1.5)
8.Secondary Outcome
Title Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item
Hide 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, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
Arm/Group Title Ziprasidone
Hide Arm/Group Description:
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Overall Number of Participants Analyzed 221
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 (n=206) 0.0  (0.4)
Week 2 (n=197) 0.0  (0.4)
Week 6 (n=168) 0.0  (0.4)
Week 10 (n=135) 0.0  (0.5)
Week 14 (n=110) 0.1  (0.6)
Week 18 (n=99) 0.0  (0.4)
Week 22 (n=82) 0.0  (0.6)
Week 26 (n=76) 0.0  (0.6)
ET (n=127) 0.0  (0.5)
Week 26 LOCF (n=206) 0.1  (0.5)
9.Secondary Outcome
Title Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score
Hide 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, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
Arm/Group Title Ziprasidone
Hide Arm/Group Description:
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Overall Number of Participants Analyzed 221
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 1 (n=206) 0.06  (1.3)
Week 2 (n=197) -0.05  (0.7)
Week 6 (n=168) -0.04  (0.9)
Week 10 (n=135) 0.02  (1.4)
Week 14 (n=110) 0.01  (0.9)
Week 18 (n=99) 0.01  (0.6)
Week 22 (n=82) 0.10  (1.2)
Week 26 (n=76) 0.08  (1.2)
ET (n=127) -0.12  (1.5)
Week 26 LOCF (n=206) 0.00  (1.0)
10.Secondary Outcome
Title Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score
Hide 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, excitement. Ratings anchored to improve consistency for 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, Weeks 2, 6, 18, 26, ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
Arm/Group Title Ziprasidone
Hide Arm/Group Description:
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Overall Number of Participants Analyzed 220
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 2 (n=196) -3.8  (7.8)
Week 6 (n=167) -6.1  (8.8)
Week 18 (n=98) -7.8  (11.0)
Week 26 (n=75) -8.5  (9.9)
ET (n=127) -4.0  (9.1)
Week 26 LOCF (n=196) -6.9  (8.9)
11.Secondary Outcome
Title Change From Baseline in Children's Global Assessment Scale (CGAS)
Hide 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, Weeks 2, 6, 18, 26, ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
Arm/Group Title Ziprasidone
Hide Arm/Group Description:
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Overall Number of Participants Analyzed 221
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 2 (n=197) 55.5  (12.9)
Week 6 (n=168) 59.2  (12.5)
Week 18 (n=99) 62.3  (11.4)
Week 26 (n=76) 65.6  (12.4)
ET (n=127) 56.6  (15.1)
Week 26 LOCF (n=197) 60.5  (14.2)
12.Secondary Outcome
Title Change From Baseline in Child Health Questionnaire (CHQ)
Hide 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, Weeks 6 and 26, ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. N=number of subjects with analyzable data at baseline; n=number of subjects with analyzable data at post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
Arm/Group Title Ziprasidone
Hide Arm/Group Description:
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Overall Number of Participants Analyzed 220
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Global Health: Week 6 (n=163) 44.2  (23.9)
Global Health: Week 26 (n=75) 50.3  (22.1)
Global Health: ET (n=124) 40.5  (25.8)
Global Health: Week 26 LOCF (n=164) 44.9  (22.9)
Global Behavior: Week 6 (n=163) 44.9  (23.6)
Global Behavior: Week 26 (n=75) 47.0  (24.2)
Global Behavior: ET (n=124) 38.7  (25.8)
Global Behavior: Week 26 LOCF (n=164) 43.8  (24.4)
Family Cohesion: Week 6 (n=163) 53.0  (23.9)
Family Cohesion: Week 26 (n=75) 54.4  (24.7)
Family Cohesion: ET (n=124) 50.0  (23.9)
Family Cohesion: Week 26 LOCF (n=164) 53.4  (23.7)
Physical Health: Week 6 (n=163) 76.4  (30.8)
Physical Health: Week 26 (n=74) 80.2  (28.8)
Physical Health: ET (n=123) 75.5  (32.8)
Physical Health: Week 26 LOCF (n=163) 77.8  (31.2)
Bodily Pain: Week 6 (n=163) 80.8  (21.6)
Bodily Pain: Week 26 (n=75) 84.4  (21.5)
Bodily Pain: ET (n=124) 81.0  (22.7)
Bodily Pain: Week 26 LOCF (n=164) 82.5  (21.3)
Emotion, Behavior: Week 6 (n=163) 53.3  (32.6)
Emotion, Behavior: Week 26 (n=74) 60.1  (31.2)
Emotion, Behavior: ET (n=123) 49.5  (34.5)
Emotion, Behavior: Week 26 LOCF (n=163) 54.8  (32.2)
Time Impact on Parent: Week 6 (n=163) 62.0  (26.6)
Time Impact on Parent: Week 26 (n=75) 69.9  (23.5)
Time Impact on Parent: ET (n=124) 59.9  (28.6)
Time Impact on Parent: Week 26 LOCF (n=164) 65.1  (26.3)
Emotional Impact on Parent: Week 6 (n=163) 49.5  (24.6)
Emotional Impact on Parent: Week 26 (n=75) 57.2  (24.7)
Emotional Impact on Parent: ET (n=124) 43.4  (25.9)
Emotional Impact on Parent: Week 26 LOCF (n=164) 52.2  (26.0)
Mental Health: Week 6 (n=163) 63.6  (16.1)
Mental Health: Week 26 (n=75) 66.7  (16.5)
Mental Health: ET (n=124) 60.8  (18.3)
Mental Health: Week 26 LOCF (n=164) 65.1  (16.1)
Physical Function: Week 6 (n=163) 80.4  (22.3)
Physical Function: Week 26 (n=75) 84.9  (19.0)
Physical Function: ET (n=124) 79.5  (23.4)
Physical Function: Week 26 LOCF (n=164) 81.4  (21.9)
Behavior Scale: Week 6 (n=163) 62.7  (16.8)
Behavior Scale: Week 26 (n=75) 64.5  (20.0)
Behavior Scale: ET (n=124) 60.2  (18.7)
Behavior Scale: Week 26 LOCF (n=164) 63.0  (18.4)
Self-Esteem: Week 6 (n=163) 52.7  (20.3)
Self-Esteem: Week 26 (n=74) 55.3  (21.0)
Self-Esteem: ET (n=124) 52.6  (21.7)
Self-Esteem: Week 26 LOCF (n=163) 54.5  (20.6)
General Health Perception: Week 6 (n=163) 50.3  (15.3)
General Health Perception: Week 26 (n=75) 51.8  (16.4)
General Health Perception: ET (n=124) 49.7  (15.1)
General Health Perception: Week 26 LOCF (n=164) 50.3  (15.4)
Family Activities: Week 6 (n=163) 60.1  (24.9)
Family Activities: Week 26 (n=75) 63.9  (24.1)
Family Activities: ET (n=124) 56.3  (27.6)
Family Activities: Week 26 LOCF (n=164) 61.6  (26.1)
Physical Health Global Subscale: Week 6 (n=163) 44.1  (11.7)
Physical Health Global Subscale: Week 26 (n=74) 46.6  (10.9)
Physical Health Global: ET (n=123) 43.8  (12.9)
Physical Health Global: Week 26 LOCF (n=163) 44.8  (12.2)
Psychosocial Health Global: Week 6 (n=163) 35.7  (10.4)
Psychosocial Health Global: Week 26 (n=74) 38.5  (10.9)
Psychosocial Health Global: ET (n=123) 33.7  (11.9)
Psychosocial Health Global: Week 26 LOCF (n=163) 36.8  (10.7)
13.Secondary Outcome
Title Number of Subjects Per Response on the School Placement Questionnaire: School Situation
Hide 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, Weeks 6 and 26, ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
Arm/Group Title Ziprasidone
Hide Arm/Group Description:
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Overall Number of Participants Analyzed 221
Measure Type: Number
Unit of Measure: participants
Baseline: Enrolled or Attend (n=221) 63
Baseline: Not Attend or Mental Illness (n=221) 59
Baseline: Not Attend or Other (n=221) 4
Baseline: Enrolled or Vacation (n=221) 26
Baseline: Not Enrolled or Mental Illness (n=221) 42
Baseline: Not Enrolled or Other (n=221) 27
Week 6: Enrolled or Attend (n=166) 68
Week 6: Not Attend or Mental Illness (n=166) 32
Week 6: Not Attend or Other (n=166) 1
Week 6: Enrolled or Vacation (n=166) 14
Week 6: Not Enrolled or Mental Illness (n=166) 29
Week 6: Not Enrolled or Other (n=166) 22
Week 26: Enrolled or Attend (n=75) 35
Week 26: Not Attend or Mental Illness (n=75) 9
Week 26: Not Attend or Other (n=75) 0
Week 26: Enrolled or Vacation (n=75) 5
Week 26: Not Enrolled or Mental Illness (n=75) 13
Week 26: Not Enrolled or Other (n=75) 13
ET: Enrolled or Attend (n=125) 42
ET: Not Attend or Mental Illness (n=125) 35
ET: Not Attend or Other (n=125) 1
ET: Enrolled or Vacation (n=125) 9
ET: Not Enrolled or Mental Illness (n=125) 21
ET: Not Enrolled or Other (n=125) 17
Week 26 LOCF: Enrolled or Attend (n=166) 75
Week 26 LOCF: Not Attend or Mental Illness (n=166) 30
Week 26 LOCF: Not Attend or Other (n=166) 1
Week 26 LOCF: Enrolled or Vacation (n=166) 8
Wk 26 LOCF: Not Enrolled or Mental Illness (n=166) 28
Week 26 LOCF: Not Enrolled or Other (n=166) 24
14.Secondary Outcome
Title Number of Subjects Per Response on the School Placement Questionnaire: School Attendance
Hide 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, Weeks 6 and 26, ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
Arm/Group Title Ziprasidone
Hide Arm/Group Description:
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: participants
Baseline: No Absences (n=133) 25
Baseline: Only a Few Absences (n=133) 37
Baseline: Frequent Absences (n=133) 12
Baseline: Did Not Attend (n=133) 36
Baseline: Not Applicable or Vacation (n=133) 23
Week 6: No Absences (n=95) 31
Week 6: Only a Few Absences (n=95) 29
Week 6: Frequent Absences (n=95) 11
Week 6: Did Not Attend (n=95) 10
Week 6: Not Applicable or Vacation (n=95) 14
Week 26: No Absences (n=42) 14
Week 26: Only a Few Absences (n=42) 16
Week 26: Frequent Absences (n=42) 7
Week 26: Did Not Attend (n=42) 0
Week 26: Not Applicable or Vacation (n=42) 5
ET: No Absences (n=62) 16
ET: Only a Few Absences (n=62) 23
ET: Frequent Absences (n=62) 5
ET: Did Not Attend (n=62) 11
ET: Not Applicable or Vacation (n=62) 7
Week 26 LOCF: No Absences (n=93) 32
Week 26 LOCF: Only a Few Absences (n=93) 32
Week 26 LOCF: Frequent Absences (n=93) 14
Week 26 LOCF: Did Not Attend (n=93) 7
Week 26 LOCF: Not Applicable or Vacation (n=93) 8
15.Secondary Outcome
Title Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance
Hide 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, Weeks 6 and 26, ET
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set. N=number of subjects analyzable for School Placement Questionnaire; n=number of subjects with analyzable data at baseline and post-baseline observation. Baseline was the last available observation from Study A1281134 (NCT00257192). LOCF imputation used for Week 26 LOCF time point.
Arm/Group Title Ziprasidone
Hide Arm/Group Description:
Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
Overall Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: participants
Baseline: Excellent (n=103) 5
Baseline: Good (n=103) 25
Baseline: Fair (n=103) 40
Baseline: Poor (n=103) 23
Baseline: Very Poor (n=103) 10
Week 6: Excellent (n=73) 2
Week 6: Good (n=73) 23
Week 6: Fair (n=73) 34
Week 6: Poor (n=73) 14
Week 6: Very Poor (n=73) 0
Week 26: Excellent (n=37) 1
Week 26: Good (n=37) 10
Week 26: Fair (n=37) 18
Week 26: Poor (n=37) 5
Week 26: Very Poor (n=37) 3
ET: Excellent (n=48) 0
ET: Good (n=48) 15
ET: Fair (n=48) 23
ET: Poor (n=48) 6
ET: Very Poor (n=48) 4
Week 26 LOCF: Excellent (n=80) 1
Week 26 LOCF: Good (n=80) 22
Week 26 LOCF: Fair (n=80) 39
Week 26 LOCF: Poor (n=80) 15
Week 26 LOCF: Very Poor (n=80) 3
Time Frame Treatment emergent adverse events are reported from time of first dose of study treatment up to 6 days after last dose of study treatment.
Adverse Event Reporting Description Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
 
Arm/Group Title Ziprasidone
Hide Arm/Group Description Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kilograms (kg). For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day [BID]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
All-Cause Mortality
Ziprasidone
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ziprasidone
Affected / at Risk (%)
Total   16/221 (7.24%) 
General disorders   
Drug ineffective  1  1/221 (0.45%) 
Nervous system disorders   
Dystonia  1  1/221 (0.45%) 
Psychiatric disorders   
Aggression  1  1/221 (0.45%) 
Agitation  1  1/221 (0.45%) 
Anxiety  1  1/221 (0.45%) 
Completed suicide  1  1/221 (0.45%) 
Delusional perception  1  1/221 (0.45%) 
Hallucination  1  1/221 (0.45%) 
Hallucination, auditory  1  2/221 (0.90%) 
Intentional self-injury  1  1/221 (0.45%) 
Major depression  1  1/221 (0.45%) 
Obsessive-compulsive disorder  1  2/221 (0.90%) 
Persecutory delusion  1  1/221 (0.45%) 
Schizophrenia  1  4/221 (1.81%) 
Schizophrenia, paranoid type  1  1/221 (0.45%) 
Self injurious behaviour  1  2/221 (0.90%) 
Suicidal behaviour  1  1/221 (0.45%) 
Suicidal ideation  1  3/221 (1.36%) 
Thinking abnormal  1  1/221 (0.45%) 
Social circumstances   
Sexual activity increased  1  1/221 (0.45%) 
Victim of sexual abuse  1  1/221 (0.45%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ziprasidone
Affected / at Risk (%)
Total   68/221 (30.77%) 
General disorders   
Fatigue  1  11/221 (4.98%) 
Nervous system disorders   
Headache  1  20/221 (9.05%) 
Somnolence  1  33/221 (14.93%) 
Tremor  1  14/221 (6.33%) 
Psychiatric disorders   
Insomnia  1  11/221 (4.98%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
The AE tables were amended to incorporate previously unreported AEs that were found during an independent audit and verified by the investigators.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
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Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00265382     History of Changes
Other Study ID Numbers: A1281135
First Submitted: December 12, 2005
First Posted: December 14, 2005
Results First Submitted: April 16, 2010
Results First Posted: May 19, 2010
Last Update Posted: December 6, 2011