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Open-label Adjunctive Zonisamide for Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT00047567
Recruitment Status : Terminated
First Posted : October 10, 2002
Last Update Posted : December 14, 2015
Sponsor:
Information provided by:
Elan Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Bipolar Disorders Drug: zonisamide Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2002
Study Completion Date : July 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
Drug Information available for: Zonisamide
U.S. FDA Resources





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

ClinicalTrials.gov Identifier: NCT00047567     History of Changes
Other Study ID Numbers: ELN-345-509
First Posted: October 10, 2002    Key Record Dates
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