Topiramate Versus Placebo as Add-on Treatment in Patients With Bipolar Disorder in the Outpatient Setting - Tabular View

Tracking Information

First Received Date ^ICMJE

October 7, 2005

Last Updated Date

April 23, 2009

Start Date ^ICMJE

October 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Changes from baseline to final visit in the Young Mania Rating Scale total score. Safety evaluations (incidence of adverse events, physical exams, vital signs, clinical laboratory tests including thyroid function tests) throughout the study.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00237289 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Changes from baseline to final visit in the Clinical Global Impressions Scale, Global Assessment Scale, Brief Psychiatric Rating Scale, and Montgomery-Asberg Depression Rating Scale. Rate of discontinuation due to efficacy failure.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bipolar Disorder

Intervention ^ICMJE

Drug: topiramate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

287

Completion Date

October 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00237289

Responsible Party

Study ID Numbers ^ICMJE

CR002653

Study Sponsor ^ICMJE

Ortho-McNeil Neurologics, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Ortho McNeil Neurologics, Inc. Clinical Trial

Ortho-McNeil Neurologics, Inc.

Information Provided By

Ortho-McNeil Neurologics, Inc.

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP