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A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Bipolar I Disorder.

This study has been terminated.

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00035802
  Purpose

A 4-week study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder with an optional 6-month open-label extension for qualified patients following completion of the study.


Condition Intervention Phase
Bipolar Disorder
Drug: Topiramate / Placebo
Phase III

MedlinePlus related topics:   Bipolar Disorder   

Drug Information available for:   Topiramate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Double-Blind Placebo-Controlled 4-Week Study of the Safety and Efficacy of Topiramate in Children and Adolescents With Acute Manic or Mixed Episodes of Bipolar I Disorder, With an Optional 6-Month Open-Label Extension
  Eligibility
Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria
  • DSM-IV diagnosis of Bipolar I Disorder (confirmed by K-SADS-P/L)
  • YMRS score greater than or equal to 20
  • General good health as determined by medical history, physical examination, and laboratory evaluations
  • Ability to swallow tablets
  • Subject's parent or guardian must be fully capable of monitoring the subject's disease process and compliance to treatment
  • Parent(s) or legal guardian(s) must read and sign the informed consent form after the nature of the study has been fully explained and assent must be obtained from subjects
  Contacts and Locations

No Contacts or Locations Provided
  More Information


Study ID Numbers:   TOPMAT-PDMD-009
First Received:   May 6, 2002
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00035802
Health Authority:   United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
bipolar  
mania  
pediatric  
children  
adolescent  

Study placed in the following topic categories:
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders
Topiramate
Psychotic Disorders

Additional relevant MeSH terms:
Anti-Obesity Agents
Pathologic Processes
Disease
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Agents
Protective Agents
Neuroprotective Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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