A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I 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 Disorder
Intervention: Topiramate (Drug)
Phase: Phase 3
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.
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.
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline to Day 21 in the total Young Mania Rating Scale (YMRS) score.
Secondary outcome: 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.
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
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.
Minimum age: 16 Years.
Maximum age: N/A.
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
Locations and Contacts
A Study of the Safety and Efficacy of Topiramate in the Treatment of Patients with Bipolar I Disorder
Ending date: May 2003
Last updated: March 14, 2007