Clinical trial NCT00237289: Topiramate Versus Placebo as add-on Treatment in Patients With Bipolar Disorder in the Outpatient Setting
Official title: Topiramate Versus Placebo as add-on Treatment in Patients With Bipolar Disorder in the Outpatient Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Manic depression
Mania
Depression
Bipolar disorder
Psychosis
Lead sponsor: Ortho-McNeil Neurologics, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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 outcomes:
measure: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Ortho-McNeil Neurologics, Inc.
name: Ortho McNeil Neurologics, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: