At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 584 enrolled

Drug / intervention

Placebo +1 moredrug

Likely dose

Placebo 80 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00280566

NCT00280566Phase 3Completed

Compare CT.gov

A Phase 3, Randomized, 6-Month, Double-Blind Trial in Subjects With Bipolar I Disorder to Evaluate the Continued Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer (vs Placebo Plus a Mood Stabilizer) Following a Minimum of 2 Months of Response to Open-Label Treatment With Both Agents

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Jan 23, 2006·Updated Mar 25, 2021

In Brief

A Phase 3 clinical trial evaluating Placebo and Ziprasidone Oral Capsule for Bipolar Mania and Bipolar Disorder. Completed, enrolled 584 participants across 107 sites in 13 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBipolar Mania, Bipolar Disorder

CountriesChile, France, Germany, Guatemala, Hong Kong, India, Italy, Mexico, Russia, Spain, Taiwan, United States, Venezuela

Collaborators--

Timeline

Phase 3CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartDec 2005

First PostedJan 2006

Primary CompletionMay 2008

TodayJul 2026

First PostedJan 23, 2006

Enrollment StartDec 1, 2005

Primary CompletionMay 1, 2008

TodayJul 2, 2026

Enrollment to primary: 2.4 yearsPosted 20.4 years ago

Interventions

Placebodrug

Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID (twice a day) for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to placebo will be tapered off the open-label ziprasidone by 20 mg BID every 2 days (in a double-blinded manner) until they are completely off ziprasidone and are on matching placebo capsules for up to 24 weeks of double-blind treatment.

Ziprasidone Oral Capsuledrug

Oral capsule formulation: Patients will be treated initially with open-label ziprasidone in the range of 40-80 mg BID for at least 10 weeks and up to 16 weeks. Patients who achieve a stable treatment regimen and whose symptoms stabilize for 8 consecutive weeks by Week 16 (Week 10 at the earliest) will be randomized. Patients randomized to ziprasidone will continue to receive the same stable treatment regimen achieved during the open-label treatment, ie, either 40 mg BID, 60 mg BID or 80 mg BID for up to 24 weeks of double-blind treatment.