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Adjunctive Zonisamide for Pediatric Bipolar Disorder
NCT00047567Phase 4
Key facts
- Status
- Terminated
- Start
- Jul 2002
- Sponsor
- Elan
- Modality
- Small Molecules
- Drugs
- zonisamide
- Conditions
- bipolar disorder (BD)
01
Overview
Phase 4, open-label, single-arm trial of zonisamide in bipolar disorder (BD), sponsored by Elan. Primary endpoints: Safety of adjunctive zonisamide and Efficacy of adjunctive zonisamide. Started Jul 2002; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Zonisamide Adjunctive
Open-label treatment with zonisamide in addition to 1-2 mood stabilizers.
03
Who it enrols
Children and adolescents with bipolar I or II disorder of average intelligence who are currently taking one or two mood stabilizers.
04
Endpoints
Primary
Safety of adjunctive zonisamide
Efficacy of adjunctive zonisamide
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