Conditions: Bipolar Disorder Depression, Bipolar
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 298
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Active treatment, double-blind, randomized treatment arm arm 2: Inactive, placebo treatment, double-blind, randomized arm

Interventions: intervention 1: Ziprasidone intervention 2: Placebo
Intervention descriptions: intervention 1: Oral capsule formulation to be administered every day for duration of patient's participation in the trial - 40 mg on Day 1; 40 mg twice a day (BID) on Day 2; Flexible BID dosing of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg or 160 mg total daily dose from Day 3 through Week 6. Dose increases of up to 40 mg/day can occur after subject has received previous lower dose for at least 1 day. intervention 2: Matching placebo oral capsules to be administered as per the instructions for the ziprasidone arm

Protocol document: