Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)

Phase 3

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Ziprasidone oral capsules; Drug: placebo oral capsules

• Registration Number: NCT00257166
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-21
• Study First Submitted QC: 2005-11-21
• Study First Posted: 2005-11-22
• Study Start: 2006-01
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Results First Submitted: 2013-05-24
• Results First Submitted QC: 2013-05-24
• Results First Posted: 2013-07-19
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

• DSM-IV criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years

Exclusion Criteria

• Imminent risk of suicide or homicide, as judged by the site investigator; any history of serious or unstable medical illness, including risk for QT prolongation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ziprasidone oral capsules	Ziprasidone oral capsules	-
Placebo	placebo oral capsules	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4	Baseline, Week 4	YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3	Baseline, Week 1, 2, 3	YMRS: an 11-item scale that measured the severity of manic episodes. Four items were rated on a scale from 0 (symptom absent) to 8 (symptom extremely severe). The remaining items were rated on a scale from 0 (symptom absent) to 4 (symptom extremely severe). YMRS total score ranged from 0 to 60, higher score indicated higher severity of mania.
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4	Baseline, Week 1, 2, 3, 4	CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill).
Clinical Global Impression - Improvement (CGI-I) Score	Week 1, 2, 3, 4	CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 West Allis, Wisconsin, United States