CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 392 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Placebo 0 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/NCT00282464
NCT00282464Phase 3Completed
CompareCT.gov

A Six-Week, Double-Blind, Multicenter, Placebo-Controlled Study Evaluating the Efficacy and Safety of Flexible Doses of Oral Ziprasidone in Outpatients With Bipolar I Depression

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Jan 26, 2006·Updated Mar 29, 2021

In Brief

A Phase 3 clinical trial evaluating Placebo and Geodon (Ziprasidone) for Bipolar Disorder. Completed, enrolled 392 participants across 43 sites.

Detailed Summary

This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed. Subjects are required to undergo a washout period of at least 7 days of any prior med.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 26, 2006
Enrollment StartFeb 1, 2006
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 20.4 years ago

Interventions

Placebodrug

Subjects will start on placebo and remain on placebo for six weeks. All cards for the Placebo arm will be 0 mg bid.

Geodon (Ziprasidone)drug

Ziprasidone flexible dosing treatment arm (20-80 mg bid). For the Ziprasidone arm, the Baseline card will contain 20 mg bid (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).