Open-label Adjunctive Zonisamide for Bipolar Disorder

NCT ID: NCT00047567

Last Updated: 2015-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2002-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bipolar Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ZONISAMIDE BIPOLAR

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

zonisamide

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Bipolar I/II
* Average intelligence
* Taking at least one, but no more than two mood stabilizers
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Elan Pharmaceuticals

INDUSTRY

Sponsor Role lead

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ELN-345-509

Identifier Type: -

Identifier Source: org_study_id