A Study of the Effectiveness and Safety of Topiramate in the Treatment of Patients With Bipolar Disorder

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00240721
First received: October 14, 2005
Last updated: June 6, 2011
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Bipolar Disorders
Mood Disorders
Affective Disorders, Psychotic
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 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

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 for the Young Mania Rating Scale (YMRS) total score.

Secondary Outcome Measures:
  • 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.

Enrollment: 363
Study Start Date: October 2000
Study Completion Date: September 2002
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 Bipolar 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) throughout 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

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), and currently experiencing a manic or mixed episode by DSM-IV and Structured Clinical 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.
  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: NCT00240721

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: NCT00240721     History of Changes
Other Study ID Numbers: CR002248
Study First Received: October 14, 2005
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
topiramate
bipolar disorders
mood disorders
manic state
depression
manic-depressive psychoses

Additional relevant MeSH terms:
Affective Disorders, Psychotic
Bipolar Disorder
Mental Disorders
Psychotic Disorders
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
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 July 31, 2014