Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00237289
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-10-07
Brief Title:
Topiramate Versus Placebo as add-on Treatment in Patients With Bipolar Disorder in the Outpatient Setting
Sponsor:
Ortho-McNeil Neurologics Inc
Organization:
Ortho-McNeil Neurologics Inc
Study Overview
Official Title:
Topiramate Versus Placebo as add-on Treatment in Patients With Bipolar Disorder in the Outpatient Setting
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None