Open-Label Adjunctive Zonisamide for Bipolar Disorder - Tabular View

Tracking Information
First Received Date ^ICMJE	October 8, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	July 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00047567 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Open-Label Adjunctive Zonisamide for Bipolar Disorder
Official Title ^ICMJE
Brief Summary	To study the safety and efficacy of zonisamide as adjunctive therapy for children and adolescents with bipolar I or II disorder.
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Bipolar Disorders
Intervention ^ICMJE	Drug: zonisamide
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	20
Completion Date	July 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	Bipolar I/II Average intelligence Taking at least one, but no more than two mood stabilizers
Gender	Both
Ages	6 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	NCT00047567
Responsible Party
Study ID Numbers ^ICMJE	ELN-345-509
Study Sponsor ^ICMJE	Elan Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Elan Pharmaceuticals
Verification Date	March 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP