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Mood Disorder Research Program

Study to Investigate the Efficacy, Safety and Tolerability of an Investigational Drug for the Treatment of Bipolar Depression

physician and patient talking

AGE: 18 - 64 years old
GENDER: All
TYPE: Interventional Treatment
HEALTHY PARTICIPANTS: No
CONDITION: Bipolar Disorder
LOCATION: University Hospitals Medical Centers

This study is currently closed to enrollment.

Study Purpose

The purpose of this research study is to evaluate if an investigational drug is safe and useful for treating patients with bipolar depression, and to compare the good and bad effects of the investigation drug to the good and bad effects of placebo. The research study is for 12 weeks and includes a prescreening phase, screening phase, double-blind treatment phase, and a post-treatment follow-up phase. The research study also includes several scheduled visits where participants will be asked detailed questions about their mood symptoms, medical history and treatments for depression, physical health and medications, collection of blood and urine samples, and additional required study questionnaires.

Who Can Participate

Participants between 18 and 64 years of age who have a primary diagnosis of bipolar disorder (BD) (Type I or II) without current psychotic features may be eligible for this study.