NCT00047567

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2002

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2002

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

First QC Date

October 8, 2002

Last Update Submit

December 10, 2015

Conditions

Keywords

ZONISAMIDEBIPOLAR

Interventions

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
* Bipolar I/II * Average intelligence * Taking at least one, but no more than two mood stabilizers

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsIsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 8, 2002

First Posted

October 10, 2002

Study Start

July 1, 2002

Study Completion

July 1, 2002

Last Updated

December 14, 2015

Record last verified: 2015-12