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.

First Received: May 6, 2002 Last Updated: June 23, 2005 History of Changes

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

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

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Topiramate

U.S. FDA Resources

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

No publications provided

Study ID Numbers:	TOPMAT-PDMD-009
Study First Received:	May 6, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00035802 History of Changes
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:

Anti-Obesity Agents
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Mood Disorders

Topiramate
Psychotic Disorders
Neuroprotective Agents
Anticonvulsants

Additional relevant MeSH terms:

Disease
Bipolar Disorder
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Pharmacologic Actions
Anti-Obesity Agents
Affective Disorders, Psychotic

Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Topiramate
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on July 02, 2009