Phase 3
Completed N=238
Safety and Efficacy of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic or Mixed)
Source: ClinicalTrials.gov NCT00257166 ↗Enrolled (actual)
238
Serious AEs
5.5%
Results posted
Jul 2013
Primary outcomePrimary: 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
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).
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 |
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
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. Informational only — not medical advice.