Overview

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