A Study on the Safety and Efficacy of Topiramate in the Treatment of Patients With Bipolar I Disorder

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Bipolar Disorder	Drug: Topiramate	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	434 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
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 Start Date :	January 2001
Actual Study Completion Date :	May 2003

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Change from baseline to Day 21 in the total Young Mania Rating Scale (YMRS) score.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

Study Director:	Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

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Additional Information:

A Study of the Safety and Efficacy of Topiramate in the Treatment of Patients with Bipolar I Disorder 

ClinicalTrials.gov Identifier:	NCT00037674 History of Changes
Other Study ID Numbers:	CR003199
First Posted:	May 21, 2002
Last Update Posted:	May 18, 2011
Last Verified:	January 2011

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Bipolar Disorder; Bipolar; Mania; Topiramate; Lithium

Additional relevant MeSH terms:

Disease; Bipolar Disorder; Pathologic Processes; Bipolar and Related Disorders; Mental Disorders; Topiramate	Anticonvulsants; Neuroprotective Agents; Protective Agents; Physiological Effects of Drugs; Anti-Obesity Agents