- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00047567
Open-label Adjunctive Zonisamide for Bipolar Disorder
December 10, 2015 updated by: Elan Pharmaceuticals
To study the safety and efficacy of zonisamide as adjunctive therapy for children and adolescents with bipolar I or II disorder.
Study Overview
Study Type
Interventional
Enrollment
20
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- Bipolar I/II
- Average intelligence
- Taking at least one, but no more than two mood stabilizers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Study Completion
July 1, 2002
Study Registration Dates
First Submitted
October 8, 2002
First Submitted That Met QC Criteria
October 9, 2002
First Posted (Estimate)
October 10, 2002
Study Record Updates
Last Update Posted (Estimate)
December 14, 2015
Last Update Submitted That Met QC Criteria
December 10, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ELN-345-509
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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National Cheng-Kung University HospitalNational Science Council, TaiwanCompleted
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Qazvin University Of Medical SciencesCompletedPatients With Bipolar DisordersIran, Islamic Republic of
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