Open-Label Adjunctive Zonisamide for Bipolar Disorder

This study has been terminated.

First Received on October 8, 2002. Last Updated on June 23, 2005 History of Changes

Sponsor:	Elan Pharmaceuticals
Information provided by:	Elan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00047567

Purpose

To study the safety and efficacy of zonisamide as adjunctive therapy for children and adolescents with bipolar I or II disorder.

Condition	Intervention	Phase
Bipolar Disorders	Drug: zonisamide	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Zonisamide

U.S. FDA Resources

Further study details as provided by Elan Pharmaceuticals:

Estimated Enrollment:	20
Study Start Date:	July 2002
Estimated Study Completion Date:	July 2002

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Bipolar I/II
Average intelligence
Taking at least one, but no more than two mood stabilizers

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00047567 History of Changes
Other Study ID Numbers:	ELN-345-509
Study First Received:	October 8, 2002
Last Updated:	June 23, 2005
Health Authority:	United States: Food and Drug Administration

Keywords provided by Elan Pharmaceuticals:

ZONISAMIDE
BIPOLAR

Additional relevant MeSH terms:

Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Zonisamide
Antioxidants
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012