Safety and Maintenance of Effect of Ziprasidone Plus a Mood Stabilizer in Bipolar I Disorder (Manic or Mixed)

Viatris

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder; Bipolar Mania

Treatments: Drug: Ziprasidone Oral Capsule; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00280566

A1281137

Details and patient eligibility

About

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.

Enrollment: 584 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

584 participants in 2 patient groups, including a placebo group

Ziprasidone

Experimental group

Description:

Active treatment, double-blind, randomized arm

Treatment:

Drug: Ziprasidone Oral Capsule

Placebo

Placebo Comparator group

Description:

Placebo treatment, double-blind, randomized arm

Treatment:

Drug: Placebo