Trial Information
Summary: A 12-week clinical research study to evaluate the efficacy and safety of carbamazepine extended release capsules administered once daily vs. twice daily in the treatment of manic symptoms of Bipolar I Disorder.
Study participants will receive carbamazepine extended release
capsules either once daily or twice daily. Patients will be allowed
to continue taking benzodiazepines, lithium, valproate, olanzapine,
risperidone and/or quetiapine during the study. 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, manic or mixed
- 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 besides Bipolar I Disorder
- Current psychiatric hospitalization
For more information,
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Contact:
Kelly Calistri, Study Coordinator
Atlanta Center for Medical Research
811 Juniper St. NE
Atlanta, GA
Telephone: 404-881-5800
Fax: 404-532-6849
Email:
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Trial listings updated: June 1, 2008 at 5:44:44 AM