drugset / Trial / NCT00237289

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

NCT00237289

Phase 3 Completed 287 enrolled Ortho-McNeil Neurologics, Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2001-10
Primary completion
Completion
2003-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Topiramate Small molecule 400 mg Oral

Indications