Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00265382
NCT00265382
Terminated
Phase 3

26-Week Open-Label Extension Study Evaluating The Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Adolescent Subjects With Schizophrenia

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country221 target enrollmentJune 2006
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsSchizophrenia
InterventionsZiprasidone oral capsules
DrugsZiprasidone oral capsules

Overview

Phase
Phase 3
Intervention
Ziprasidone oral capsules
Conditions
Schizophrenia
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment
221
Locations
1
Primary Endpoint
Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Status
Terminated
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in adolescents (ages 13-17) with schizophrenia.

Detailed Description

On March 24, 2009, Pfizer Inc. stopped late stage Geodon pediatric clinical trials in schizophrenia (A1281134 - placebo controlled; A1281135 - open label). As recommended by the DSMB, these studies were stopped due to lack of efficacy. No safety concerns were identified.

Registry
clinicaltrials.gov
Start Date
June 2006
End Date
June 2009
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Participation in double-blind treatment study A1281134, meeting specific criteria of duration and safety

Exclusion Criteria

  • •Imminent risk of suicide or homicide, as judged by the site investigator
  • •Serious adverse event related to study medication in study A1281134
  • •Significant prolongation of QT interval in study A1281134

Arms & Interventions

Open

Intervention: Ziprasidone oral capsules

Outcomes

Primary Outcomes

Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time Frame: 26 weeks

All observed or volunteered treatment-emergent AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.

Secondary Outcomes

  • Number of Subjects With Change From Baseline to Each Pubertal Stage of Development as Assessed by the Tanner Adolescent Pubertal Self Assessment(Baseline, Week 26, Early Termination (ET))
  • Change From Baseline in Children's Problem Behavior and Aggression Questionnaire (CPBAQ) Total Score(Baseline, Weeks 2, 6, 18, 26, ET)
  • Change From Baseline in Child Depression Rating Scale - Revised (CDRS-R): Total Score(Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET)
  • Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales(Baseline, Weeks 6 and 26, ET)
  • Change From Baseline in CNS Vital Signs Cognitive Test Battery: Neurocognitive Index(Baseline, Weeks 6 and 26, ET)
  • Change From Baseline in Simpson-Angus Rating Scale (SARS)(Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET)
  • Change From Baseline in Barnes Akathisia Rating Scale (BAS) Global Clinical Assessment Item(Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET)
  • Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Cluster Score(Baseline, Weeks 1, 2, 6, 10, 14, 18, 22, 26, ET)
  • Change From Baseline in Brief Psychiatric Rating Scale - Anchored (BPRS-A) Total Score(Baseline, Weeks 2, 6, 18, 26, ET)
  • Change From Baseline in Children's Global Assessment Scale (CGAS)(Baseline, Weeks 2, 6, 18, 26, ET)
  • Change From Baseline in Child Health Questionnaire (CHQ)(Baseline, Weeks 6 and 26, ET)
  • Number of Subjects Per Response on the School Placement Questionnaire: School Situation(Baseline, Weeks 6 and 26, ET)
  • Number of Subjects Per Response on the School Placement Questionnaire: School Attendance(Baseline, Weeks 6 and 26, ET)
  • Number of Subjects Per Response on the School Placement Questionnaire: Overall School Performance(Baseline, Weeks 6 and 26, ET)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 3
Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)Bipolar Disorder
NCT00265330Pfizer's Upjohn has merged with Mylan to form Viatris Inc.169
Withdrawn
Phase 3
Safety And Tolerability Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)Bipolar Disorder
NCT01124877Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Completed
Phase 3
Extension Study of Patients Successfully Treated by Ziprasidone in Study A1281031Schizophrenia
NCT00174447Pfizer's Upjohn has merged with Mylan to form Viatris Inc.43
Completed
Phase 4
A Study of Ziprasidone for the Treatment of Psychosis in Patients Who Had Already Had Benefits From Ziprasidone Treatment in a Previous StudyPyschotic Disorders
NCT00645320Pfizer's Upjohn has merged with Mylan to form Viatris Inc.75
Completed
Phase 3
An Open-label Extension Study to Evaluate the Safety and Tolerability of Licarbazepine 750-2000 mg/d in the Treatment of Manic Episodes of Bipolar I DisorderBipolar I Disorder
NCT00238485Novartis251