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Sponsored by: |
Ortho-McNeil Neurologics, Inc. |
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Information provided by: | Ortho-McNeil Neurologics, Inc. |
ClinicalTrials.gov Identifier: | NCT00237289 |
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 |
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Bipolar Disorder |
Drug: topiramate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Topiramate Versus Placebo as Add-on Treatment in Patients With Bipolar Disorder in the Outpatient Setting |
Estimated Enrollment: | 260 |
Study Start Date: | October 2001 |
Estimated Study Completion Date: | October 2003 |
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR002653 |
Study First Received: | October 7, 2005 |
Last Updated: | May 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00237289 |
Health Authority: | United States: Institutional Review Board |
Mania Depression Psychosis Bipolar disorder Manic depression |
Affective Disorders, Psychotic Depression Mental Disorders Bipolar Disorder |
Mood Disorders Topiramate Psychotic Disorders Depressive Disorder |
Anti-Obesity Agents Pathologic Processes Disease Therapeutic Uses Physiological Effects of Drugs |
Protective Agents Neuroprotective Agents Central Nervous System Agents Pharmacologic Actions Anticonvulsants |