Open-label Adjunctive Zonisamide for Bipolar Disorder

This study has been terminated.
Information provided by:
Elan Pharmaceuticals Identifier:
First received: October 8, 2002
Last updated: December 10, 2015
Last verified: December 2015
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 4

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:

Further study details as provided by Elan Pharmaceuticals:

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

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  • Bipolar I/II
  • Average intelligence
  • Taking at least one, but no more than two mood stabilizers
  Contacts and Locations
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No Contacts or Locations Provided
  More Information Identifier: NCT00047567     History of Changes
Other Study ID Numbers: ELN-345-509 
Study First Received: October 8, 2002
Last Updated: December 10, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Elan Pharmaceuticals:

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mental Disorders
Mood Disorders
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on April 27, 2016