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Safety And Tolerability Of Ziprasidone In Adolescents With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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):

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

  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


  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


  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.


  More Information