Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00394095
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2006-10-27
Brief Title:
Topiramate vs Placebo in Preventing Weight Gain in Bipolar Disorder Treated With Olanzapine
Sponsor:
University of Cincinnati
Organization:
University of Cincinnati
Study Overview
Official Title:
A Double-Blind Randomized Placebo-Controlled Pilot Study of Topiramate vs Placebo in Combination With Olanzapine for the Prevention of Weight Gain in Manic or Mixed Youth With Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2024-09
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 primary objective of this study is to examine the efficacy of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder The secondary objective is to examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder
Detailed Description:
After consent and screening patients will be initiated on 5mg or 10mg per day of olanzapine Olanzapine doses will be titrated to 10-20 mg of olanzapine over one week to a maximum of 20mg by day 21 Patients will also receive either topiramate 25mg bid titrated over 18 days to 150 mg bid with flexibility to titrate to 200mg bid or matched placebo Topiramate will be initiated at a dose of 25 mg bid and will be increased by 25 mg bid every three days as tolerated Patients will be evaluated by a blinded to treatment status and adverse events rater
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