Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00240721
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-10-14
Brief Title:
A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar 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 Subjects With Bipolar I Disorder With An Optional Open-Label Extension
Status:
COMPLETED
Status Verified Date:
2010-11
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 effectiveness and safety 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 effectiveness of two dose levels of topiramate 400 and 600 milligramsday compared with placebo in the treatment of acute manic or mixed episodes in patients with Bipolar 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 Assessment of effectiveness include change from baseline to Day 21 for the Young Mania Rating Scale YMRS total score Also included 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 rate of withdrawal from the study due to adverse events and vital signs blood pressure and pulse throughout the study as well as changes in clinical laboratory tests hematology biochemistry 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 Topiramate tablets 50 or 100 milligrams or placebo beginning at 50mg daily and increasing over the first week to a maximum of 400mgday or 600mgday depending on study group Maximum dosage continues up to 12 weeks Dosage can be decreased or increased at investigators discretion
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