Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037674
Status:
COMPLETED
Last Update Posted:
2011-05-18
First Post:
2002-05-20
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 Two Doses of Topiramate for the Treatment of Acute Manic or Mixed Episodes in Patients With 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:
This primary purpose of this study is to evaluate the safety and efficacy of topiramate compared with lithium or 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- and active-controlled study to evaluate the effectiveness of two dose levels of topiramate 200 and 400 milligramsday compared with lithium and placebo in the treatment of acute manic or mixed episodes in patients with Biplar I Disorder 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 for the total Young Mania Rating Scale YMRS score Also included as efficacy assessments during the 12 week study are the Global Assessment Scale GAS Montgomery-Åsberg Depression Rating Scale MADRS Brief Psychiatric Rating Scale BPRS Clinical Global Impressions CGI 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 Young Mania Rating Scale YMSR total 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 tablets 50 milligramsmg increasing from once daily 50mg to 3-times daily target total daily dose 200mg or 400mg maintained through Week 12 Lithium oral capsules 300mg increasing from once daily 300mg to three-times daily target total daily dose 1500-1800 mg
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