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NCT00047567 Clinical Trial

Open-label Adjunctive Zonisamide for Bipolar Disorder

Bipolar Disorders Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00047567
Other study ID # ELN-345-509
Secondary ID
Status Terminated
Phase Phase 4
First received October 8, 2002
Last updated December 10, 2015
Start date July 2002
Est. completion date July 2002

Study information
Verified date December 2015
Source Elan Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Terminated
Enrollment 20
Est. completion date July 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 17 Years
Eligibility - Bipolar I/II

- Average intelligence

- Taking at least one, but no more than two mood stabilizers

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• zonisamide

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Elan Pharmaceuticals
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