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Open-label Adjunctive Zonisamide for Bipolar Disorder

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00047567
First Posted: October 10, 2002
Last Update Posted: December 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Elan Pharmaceuticals
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

ClinicalTrials.gov Identifier: NCT00047567     History of Changes
Other Study ID Numbers: ELN-345-509
First Submitted: October 8, 2002
First Posted: October 10, 2002
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by Elan Pharmaceuticals:
ZONISAMIDE
BIPOLAR

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Zonisamide
Anticonvulsants
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs