- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00037674
A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder
May 17, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
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.
Study Overview
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 milligrams/day) 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 milligrams[mg]); 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 Type
Interventional
Enrollment (Actual)
434
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of Bipolar I Disorder by criteria of Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I
- )
- At least one previous manic or mixed episode
- Meeting minimum severity criteria (a Young Mania Rating Scale [YMRS] score of >=20 at screening and baseline visits) for the current acute manic or mixed episode
- Females must be postmenopausal, surgically sterile, or using adequate contraceptive measures, and have a negative pregnancy test
Exclusion Criteria:
- DSM-IV diagnosis of alcohol or substance dependence (with the exception of nicotine or caffeine dependence)
- DSM-IV Axis I diagnosis of schizoaffective disorder or impulse control disorder
- Experienced a manic episode while taking an antidepressant or psychostimulant drug
- Known hypersensitivity to topiramate or previously participated in a topiramate study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Change from baseline to Day 21 in the total Young Mania Rating Scale (YMRS) score.
|
Secondary Outcome Measures
Outcome Measure |
---|
Change from baseline to Day 21 and Week 12 in scores of MADRS, BPRS, CGI, and GAS. Response to treatment, indicated by no longer meeting DSM-IV criteria for manic/mixed episode. Incidence of adverse events monitored throughout the study.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2001
Study Completion (Actual)
May 1, 2003
Study Registration Dates
First Submitted
May 20, 2002
First Submitted That Met QC Criteria
May 20, 2002
First Posted (Estimate)
May 21, 2002
Study Record Updates
Last Update Posted (Estimate)
May 18, 2011
Last Update Submitted That Met QC Criteria
May 17, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR003199
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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