Phase 3 N=238 Randomized Double-blind Treatment

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

Bipolar Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00257166 ↗

Enrolled (actual)

238

Serious AEs

5.5%

Results posted

Jul 2013

Primary outcome: Primary: Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4 — 26.2; 27.0; -13.8; -9.9 units on a scale — p=0.0005

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ziprasidone oral capsules (Drug); placebo oral capsules (Drug)
Age: Pediatric · 10+ yrs
Sex: All
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Primary completion: Jul 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 4	26.2; 27.0; -13.8; -9.9	0.0005 sig
SECONDARY Change From Baseline in Young Mania Rating Scale (YMRS) Score at Week 1, 2 and 3	-9.3; -6.3; -11.5; -8.1; -13.0; -9.0	0.0006 sig
SECONDARY Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 1, 2, 3 and 4	4.5; 4.5; -0.9; -0.5; -1.1; -0.6	0.0002 sig
SECONDARY Clinical Global Impression - Improvement (CGI-I) Score	2.8; 3.4; 2.5; 3.2; 2.4; 3.1	0.0004 sig

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).

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00257166). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.