Status:
COMPLETED
Topiramate Versus Placebo as add-on Treatment in Patients With Bipolar Disorder in the Outpatient Setting
Lead Sponsor:
Ortho-McNeil Neurologics, Inc.
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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) t...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2003
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT00237289
Start Date
October 1 2001
End Date
October 1 2003
Last Update
May 19 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.