Open-Label Adjunctive Zonisamide for Bipolar Disorder

This study has been terminated.

Sponsor:

Information provided by:

Elan Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00047567

First received: October 8, 2002

Last updated: June 23, 2005

Last verified: March 2004

History of Changes

Tracking Information
First Received Date ^ICMJE	October 8, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	July 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00047567 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Open-Label Adjunctive Zonisamide for Bipolar Disorder
Official Title ^ICMJE	Not Provided
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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Bipolar Disorders
Intervention ^ICMJE	Drug: zonisamide
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	20
Completion Date	July 2002
Primary Completion Date	Not Provided
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	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00047567
Other Study ID Numbers ^ICMJE	ELN-345-509
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Elan Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
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

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