Trial Information

Summary: An 8-week clinical research study to evaluate the use of carbamazepine extended release capsules in combination with other psychotropic medications for the treatment of Bipolar I Disorder.

This study is seeking outpatients who are currently receiving olanzapine, risperidone, quetiapine or aripiprazole alone or in combination with a mood stabilizer (lithium, valproate or lamotrigine). Carbamazepine extended release capsules will be added to current therapy as lamotrigine and valproate are slowly discontinued. The use of benzodiazepines during the study will also be allowed. This study is currently enrolling.

Patients must meet the following criteria:

• Male or female outpatients over the age of 18
• Diagnosis of Bipolar I Disorder, mixed or manic
• Currently experiencing a manic or mixed episode
• A history of at least one prior manic or mixed episode

Patients will be excluded for any of the following reasons:

• More than 6 mood episodes per year
• At immediate risk for suicidal or violent behavior
• Heart attack within 6 months
• History of seizure disorder
• Psychiatric disorder other than Bipolar I Disorder
• Current psychiatric hospitalization

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Trial listings updated: June 1, 2008 at 5:44:44 AM