Open-label Adjunctive Zonisamide for Bipolar Disorder

Elan Pharmaceuticals

Status and phase: Terminated; Phase 4

Conditions: Bipolar Disorders

Treatments: Drug: zonisamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00047567

ELN-345-509

Details and patient eligibility

About

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

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Bipolar I/II
• Average intelligence
• Taking at least one, but no more than two mood stabilizers

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)