Trial Information

Summary: A six-week, randomized, double-blind, multicenter, fixed-flexible dose, placebo-controlled study evaluating the efficacy and safety of oral ziprasidone in outpatients with Bipolar I depression

The MGH Bipolar Clinic and Research Program is currently seeking volunteers to participate in a research study evaluating a medication in the treatment of patients with bipolar I depression. The purpose of this research study is to examine the effectiveness of ziprasidone (Geodon) compared to placebo (contains no active medication) in the treatment of patients with bipolar I depression. Ziprasidone is an antipsychotic medication that is currently approved for the treatment of schizophrenia and bipolar manic and mixed states, but has not yet been proven to be effective in treating depression in patients with bipolar I. In this study, patients will receive either a high or low-dose of ziprasidone or placebo for 6 weeks. This study involves extensive screening and baseline visits, followed by 6 weekly visits. Eligible patients will receive study visits, laboratory tests, and physical examinations at no cost. Bipolar patients above the age of 18, who are currently depressed and have had a prior manic or mixed episode, please contact Claire at catilley@partners.org or call (617) 726-7591or 1-866-99-MOODS for more information.
IRB# 2005P001212

If you would like to learn more about participating in this study, please send an e-mail message using the form below.