Adjunctive Ziprasidone in the Treatment of Bipolar I Depression

Viatris

Status and phase: Completed; Phase 3

Conditions: Depression, Bipolar; Bipolar Disorder

Treatments: Drug: Placebo; Drug: Ziprasidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00483548

A1281158

Details and patient eligibility

About

The purpose of this study is to determine if a treatment regimen of ziprasidone plus a mood stabilizer is safe and effective in the short term treatment of Bipolar I Depression. Ziprasidone will be added to lithium, valproate or lamotrigine after the patient has been on a therapeutic dose of one of these mood stabilizers for at least 4 weeks.

Enrollment: 298 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for Bipolar I disorder, most recent episode depressed, with or without rapid cycling and without psychotic features. Subjects receive therapeutic dose of lithium, valproate or lamotrigine for at least 4 weeks prior to randomization.

Exclusion criteria

• Patients with ultra-fast rapid cycling (8 or more mood episodes per year)
• Significant heart disease including abnormalities in the heart's rhythm (QT prolongation)
• Psychotic symptoms (hallucinations and/or delusions).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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298 participants in 2 patient groups, including a placebo group

Ziprasidone

Experimental group

Description:

Active treatment, double-blind, randomized treatment arm

Treatment:

Drug: Ziprasidone

Placebo

Placebo Comparator group

Description:

Inactive, placebo treatment, double-blind, randomized arm

Treatment:

Drug: Placebo