Topiramate Versus Placebo as add-on Treatment in Patients With Bipolar Disorder in the Outpatient Setting

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of adding topiramate as compared to placebo to the medications a patient with bipolar disorder is already taking (lithium or valproate) to see if adding topiramate will better control the patient's manic symptoms.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ortho-McNeil Neurologics, Inc.
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Confirmed diagnosis of Bipolar Disorder Type I

• Total Young Mania Rating Scale (YMRS) score of 18 or higher

• Currently being treated with a mood stabilizer (lithium or valproate)

• Having a stable therapeutic dose of the mood stabilizer in their bloodstream

• Currently not requiring hospitalization

Exclusion Criteria:

• Patients taking an antidepressant or anti-seizure medication

• Hospitalized paitents

• Women who are pregnant or breast-feeding

• Women who are not using birth control

• Patients with history of drug or alcohol abuse