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

This study has been completed.
Sponsor:
Information provided by:
Ortho-McNeil Neurologics, Inc.
ClinicalTrials.gov Identifier:
NCT00237289
First received: October 7, 2005
Last updated: May 17, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Drug: topiramate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Topiramate Versus Placebo as add-on Treatment in Patients With Bipolar Disorder in the Outpatient Setting

Resource links provided by NLM:


Further study details as provided by Ortho-McNeil Neurologics, Inc.:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 287
Study Start Date: October 2001
Study Completion Date: October 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00237289

Sponsors and Collaborators
Ortho-McNeil Neurologics, Inc.
Investigators
Study Director: Ortho McNeil Neurologics, Inc. Clinical Trial Ortho-McNeil Neurologics, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00237289     History of Changes
Other Study ID Numbers: CR002653
Study First Received: October 7, 2005
Last Updated: May 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Ortho-McNeil Neurologics, Inc.:
Manic depression
Mania
Depression
Bipolar disorder
Psychosis

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on August 20, 2014