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

Tracking Information
First Received Date ^ICMJE	May 6, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00035802 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Bipolar I Disorder.
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Bipolar Disorder
Intervention ^ICMJE	Drug: Topiramate / Placebo
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	13 Years to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00035802
Responsible Party
Study ID Numbers ^ICMJE	TOPMAT-PDMD-009
Study Sponsor ^ICMJE	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date	October 2002
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP