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

NCT ID: NCT00237289

Last Updated: 2011-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 287 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2003-10-31

Brief 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.

Detailed Description

Many patients with bipolar disorder (manic-depressive illness) require more than one medication to control their symptoms. This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel-groupd study to evalute the efficacy and safety of topiramate versus placebo as add-on therapy to lithium or valproate for the treatment of bipolar 1 disorder as an outpatient setting. These patients must already be taking either lithium or valproate for at least 6 weeks before the first visit and have been on the same dose of the mood stabilizer for at least 2 weeks before the first visit. Paitents will be randomized to receive either placebo or topiramate, an anti-seizure medication not approved for the treatment of bipolar disorder, in addition to their lithium or valporate. The study consists of 56-day titration (topiramate will be titrated up to 400mg per day or the maximum tolerated dose), 28-day continuation period, and 7 days of follow-up to taper off the medication. The study hypothesis is that topiramate will be more effective than placebo in the treatment of mania in type 1 bipolar disorder patients as measured by the Young Mania Rating Scale (YMRS) and will be well tolerated. YMRS is a questionnaire consisting of 11 items designed to assess severity of mania symptoms.

Patients will start taking topiramate 25 mg per day or placebo by mouth. Over the next 8 weeks, doses will be increased to up to 400 mg per day or to the maximum tolerated dose, whichever is lower. After the first 8 weeks, patients will stay at the established dose for the next 4 weeks.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

topiramate

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho-McNeil Neurologics, Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Ortho McNeil Neurologics, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Ortho-McNeil Neurologics, Inc.

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=915&filename=CR002653_CSR.pdf

Topiramate Versus Placebo as Add-On Treatment in Patients with Bipolar Disorder in the Outpatient Setting

Other Identifiers

CR002653

Identifier Type: -

Identifier Source: org_study_id