Phase 3
N=584
Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)
Bipolar Mania · Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00280566 ↗Enrolled (actual)
584
Serious AEs
—
Results posted
Dec 2009
Primary outcome: Primary: Time to Intervention for a Mood Episode During Double Blind Period — 172.159; 143.133 Days — p=0.0104
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Ziprasidone Oral Capsule (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Intervention for a Mood Episode During Double Blind Period |
172.159; 143.133 | 0.0104 sig |
| SECONDARY Time to Discontinuation for Any Reason During Double Blind Period 2 |
153.526; 123.313 | 0.0047 sig |
| SECONDARY Modified Time to Intervention for a Mood Episode (TIME) |
168.145; 140.325 | 0.0205 sig |
| SECONDARY Change From Baseline in Mania Rating Scale (MRS) by Visit During Double Blind Period |
-0.2; 0.8; -0.4; -0.1; -0.6; 0.2 | 0.1247 |
| SECONDARY Change From Baseline in Clinical Global Impression Severity (CGI-S) Score by Visit During Double Blind Period |
0.1; 0.3; 0.2; 0.2; -0.0; 0.1 | 0.0088 sig |
| SECONDARY Clinical Global Impression - Improvement (CGI-I) Score by Visit During Double Blind Period |
2.3; 2.8; 2.4; 2.6; 2.3; 2.5 | 0.0013 sig |
| SECONDARY Change From Baseline in Montgomery-Asberg Rating Scale (MADRS) Score by Visit During Double Blind Period |
-0.2; 2.7; 1.1; 2.7; -0.3; 1.6 | 0.0023 sig |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score by Visit During Double Blind Period |
0.4; 1.5; -0.1; -0.8; -0.1; 0.3 | 0.5954 |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Postive Scale by Visit During Double Blind Period |
0.0; 0.1; -0.2; -0.2; -0.3; 0.3 | 0.9538 |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Negative Scale by Visit During Double Blind Period |
0.2; 0.4; 0.2; -0.1; 0.1; 0.1 | 0.8117 |
Summary
The purpose of this study is to determine if ziprasidone plus a mood stabilizer will continue to be a safe and effective treatment regimen for adults with Bipolar I Disorder (manic or mixed symptoms) after they have achieved 8 consecutive weeks of symptom improvement on the regimen.
Eligibility Criteria
Inclusion Criteria
Adults meeting DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria for Bipolar I Disorder (currently with manic or mixed symptoms)
Exclusion Criteria
Ultra rapid cyclers and subjects with significant cardiovascular disease including history of QT prolongation and/or congenital long QT syndrome
Data sourced from ClinicalTrials.gov (NCT00280566). 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.