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
  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
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
  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 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 ]

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


  More Information