Safety And Tolerability 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:
NCT00265382
First received: December 12, 2005
Last updated: December 2, 2011
Last verified: December 2011
Results First Received: April 16, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: Ziprasidone oral capsules

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ziprasidone 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).

Participant Flow:   Overall Study
    Ziprasidone  
STARTED     221  
COMPLETED     76  
NOT COMPLETED     145  
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  



  Baseline Characteristics
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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 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).

Baseline Measures
    Ziprasidone  
Number of Participants  
[units: participants]
  221  
Age, Customized [1]
[units: Participants]
 
>12 years and <13 years at start of treatment     3  
13 to 17 years     218  
Gender  
[units: Participants]
 
Female     90  
Male     131  
[1] Baseline data are from the preceding Study A1281134 (NCT00257192).



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: 26 weeks ]

2.  Secondary:   Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment   [ Time Frame: Baseline, Week 26, Early Termination (ET) ]

3.  Secondary:   Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score   [ Time Frame: Baseline, Weeks 2, 6, 18, 26, ET ]

4.  Secondary:   Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score   [ Time Frame: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET ]
  Hide Outcome Measure 4

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, Weeks 1, 2, 6, 10, 14, 18, 22, 26, 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.
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.

Reporting Groups
  Description
Ziprasidone 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).

Measured Values
    Ziprasidone  
Number of Participants Analyzed  
[units: participants]
  214  
Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score  
[units: scores on a scale]
Mean ± Standard Deviation
 
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  

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



5.  Secondary:   Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales   [ Time Frame: Baseline, Weeks 6 and 26, ET ]

6.  Secondary:   Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index   [ Time Frame: Baseline, Weeks 6 and 26, ET ]

7.  Secondary:   Change From Baseline in Simpson-Angus Rating Scale (SARS)   [ Time Frame: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET ]

8.  Secondary:   Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item   [ Time Frame: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET ]

9.  Secondary:   Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score   [ Time Frame: Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET ]

10.  Secondary:   Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score   [ Time Frame: Baseline, Weeks 2, 6, 18, 26, ET ]

11.  Secondary:   Change From Baseline in Children's Global Assessment Scale (CGAS)   [ Time Frame: Baseline, Weeks 2, 6, 18, 26, ET ]

12.  Secondary:   Change From Baseline in Child Health Questionnaire (CHQ)   [ Time Frame: Baseline, Weeks 6 and 26, ET ]

13.  Secondary:   Number of Subjects Per Response on the School Placement Questionnaire: School Situation   [ Time Frame: Baseline, Weeks 6 and 26, ET ]

14.  Secondary:   Number of Subjects Per Response on the School Placement Questionnaire: School Attendance   [ Time Frame: Baseline, Weeks 6 and 26, ET ]

15.  Secondary:   Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance   [ Time Frame: Baseline, Weeks 6 and 26, ET ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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.


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: NCT00265382     History of Changes
Other Study ID Numbers: A1281135
Study First Received: December 12, 2005
Results First Received: April 16, 2010
Last Updated: December 2, 2011
Health Authority: United States: Food and Drug Administration