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Open-Label Adjunctive Zonisamide for Bipolar Disorder

This study has been terminated.

Sponsored by: 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

MedlinePlus related topics:   Bipolar Disorder   

Drug Information available for:   Zonisamide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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


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

Keywords provided by Elan Pharmaceuticals:
ZONISAMIDE  
BIPOLAR  

Study placed in the following topic categories:
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder
Zonisamide
Mood Disorders
Psychotic Disorders

Additional relevant MeSH terms:
Antioxidants
Pathologic Processes
Disease
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Agents
Protective Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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