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Open-Label Adjunctive Zonisamide for Bipolar Disorder

This study has been terminated.
Sponsor:
Information provided by:
Elan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00047567
First received: October 8, 2002
Last updated: June 23, 2005
Last verified: March 2004
History of Changes
  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
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 May 16, 2013