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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00035230
First received: May 2, 2002
Last updated: June 6, 2011
Last verified: January 2011
  Purpose

The primary purpose of this study is to evaluate the safety and efficacy of topiramate compared with placebo in the treatment of acute manic or mixed episodes in patients with Bipolar I Disorder.


Condition Intervention Phase
Bipolar Disorder
Drug: Topiramate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Multicenter, Placebo-Controlled 12-Week Study of the Safety and Efficacy of Topiramate in Patients With Acute Manic or Mixed Episodes of Bipolar I Disorder With an Optional Open-Label Extension

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Change from baseline to Day 21 in the total Young Mania Rating Scale (YMRS) score.

Secondary Outcome Measures:
  • Changes from baseline to Day 21 and Week 12 in the scores of CGI, MADRS, BPRS, 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.

Enrollment: 338
Study Start Date: July 2001
Study Completion Date: November 2002
Detailed Description:

This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of topiramate (400 milligrams/day) compared with placebo in the treatment of acute manic or mixed episodes in patients with Biplar I Disorder. In addition, a third group of patients will be treated with lithium (1500milligrams/day) as a comparator drug. 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 in the Young Mania Rating Scale (YMRS) score. Also included as efficacy assessments during the 12 week study are the Clinical Global Impressions (CGI) scale, Global Assessment Scale (GAS), Montgomery-Åsberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS), 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 the total Young Mania Rating Scale (YMSR) 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 capsule will be increased from once daily (50mg) to 3 times daily up to target total daily dose 400mg, maintained through Week 12. Lithium oral capsules will be increased from once daily (300mg) to 3 times daily up to target total daily dose of 1500mg, maintained through Week 12.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
  • )
  • Currently in a manic or mixed episode and at least one previous manic or mixed episode
  • meet 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035230

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00035230     History of Changes
Other Study ID Numbers: CR003232
Study First Received: May 2, 2002
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Bipolar disorders
Bipolar
mania
Topiramate
Lithium

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on August 26, 2014