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

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