Bipolar and Depression Clinical Trial

Contact Information

Name: Kathy Beck, MSW
Phone: 202/994-2273
2300 K Street, NW, Suite 205
Washington, DC 20037

Hours Of Operation: 8:30am - 5:00pm Monday - Friday

Protocol ID: CN138-146
Primary Investigator: Daniel Lieberman, MD

Protocol Description

The Department of Psychiatry of The George Washington University Medical Center is participating in a multi-center research trial sponsored by Bristol-Myers Squibb to establish the safety and effectiveness of Aripiprazole as treatment in outpatients with Bipolar I Disorder with a Major Depressive Disorder without psychotic features.  These patients must have had two prior mood episodes in the past 2 years, with at least one a manic or mixed episode that required treatment.
Approximately 420 patients will be enrolled in the study from 35 centers.  Approximately 10 subjects will be enrolled at the George Washington University Medical Center. The length of the study is 8 to 34 weeks. 

Eligibility Criteria

  • Males and Females between age 18 and 65 years
  • Must have had a positive response to medication for the treatment of mania in the past
  • Must have at least moderate depressive symptoms currently
  • Must have minimal or no current manic symptoms

Registration Information

Patients diagnosed with a late onset depression or with their first depressive episode Recurrent depressive episodes that have been treatment resistant or spontaneously remitted Any patient with a diagnosis of Bipolar I Disorder, mixed type, or with psychotic features, rapid cyclers, or Bipolar II disorder Failure of 2 adequate trials of an anti-depressant or a mood stabilizer in previous or current depressive episode Patients suffering from OCD (Obsessive Compulsive Disorder), Bulimia, or ADHD within the past 3 months Patients with a history of cognitive disorders, psychotic disorders, or personality disorders Patients who represent a significant risk of suicide

Last Update

March 27, 2008
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