A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar Disorder
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorders; Affective Disorders, Psychotic; Mood Disorders
Intervention: topiramate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline to Day 21 for the Young Mania Rating Scale (YMRS) total score.
Secondary outcome: Change from baseline to Day 21 for scores on MADRS, BPRS, CGI, and GAS; response to treatment, indicated by not any longer meeting DSM-IV criteria for manic/mixed episode.
Detailed description:
This is a randomized, double-blind, placebo-controlled study to evaluate the effectiveness of
two dose levels of topiramate (400 and 600 milligrams/day) compared with 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. 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) througout 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 400mg/day or 600mg/day, depending on study group. Maximum
dosage continues up to 12 weeks. Dosage can be decreased or increased at investigator's
discretion.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Diagnosis of Bipolar I Disorder by criteria of Diagnostic and Statistical Manual of Mental
Diseases, 4th edition (DSM-IV), and currently experiencing a manic or mixed episode by
DSM-IV and Structured Clinial Interview criteria
Experienced at least one previous manic or mixed episode
Young Mania Rating Scale (YMSR) score >=20
Physically healthy
Females must be postmenopausal, surgically sterile, or using adequate contraceptive
measures, and have a negative pregnancy test
Exclusion Criteria:
Diagnosis of alcohol or substance dependence (with the exception of nicotine or caffeine
dependence) by DSM-IV criteria
DSM-IV Axis I diagnosis of schizoaffective disorder or impulse control disorder
Experienced a manic episode while taking an antidepressant or psychostimulant drug
No significant and untreated or unstable medical illness of the liver, kidney, heart,
lungs, or endocrine system
No hypersensitivity to topiramate or have previously participated in a topiramate study
Locations and Contacts
Additional Information
A study of the effectiveness and safety of topiramate in the treatment of patients with Bipolar Disorder
Starting date: September 2000
Ending date: September 2002
Last updated: May 18, 2007
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