Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035230
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2002-05-02
Brief Title:
A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Double-Blind Multicenter Placebo-Controlled 12-Week Study of the Safety and Efficacy of Topiramate in Patients With Acute Manic or Mixed Episodes of Bipolar I Disorder With an Optional Open-Label Extension
Status:
COMPLETED
Status Verified Date:
2011-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to evaluate the safety and efficacy of topiramate compared with placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder
Detailed Description:
This is a randomized double-blind placebo-controlled study to evaluate the safety and efficacy of topiramate 400 milligramsday compared with placebo in the treatment of acute manic or mixed episodes in patients with Biplar I Disorder In addition a third group of patients will be treated with lithium 1500milligramsday as a comparator drug The trial consists of 3 phases a screening period double-blind treatment for 12 weeks and an optional open-label period of at least 6 months Efficacy assessments include the change from baseline to Day 21 in the Young Mania Rating Scale YMRS score Also included as efficacy assessments during the 12 week study are the Clinical Global Impressions CGI scale Global Assessment Scale GAS Montgomery-Åsberg Depression Rating Scale MADRS Brief Psychiatric Rating Scale BPRS and health-related quality of life measures at specified time intervals Safety assessments include evaluation of adverse events throughout the study rate of withdrawal from the study due to adverse events and vital signs blood pressure and pulse througout the study as well as changes in clinical laboratory tests hematology chemistry urinalysis electrocardiograms ECGs and physical examinations at specified times The study hypothesis is that the change from baseline in the total Young Mania Rating Scale YMSR score at Day 21 will be significantly better for the topiramate groups than for the placebo group and that the study drug will be well tolerated by the patients Topiramate oral capsule will be increased from once daily 50mg to 3 times daily up to target total daily dose 400mg maintained through Week 12 Lithium oral capsules will be increased from once daily 300mg to 3 times daily up to target total daily dose of 1500mg maintained through Week 12
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