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Pilot Evaluation of Levetiracetam in Bipolar Illness
NCT00015769Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2001
- Countries
- 1
- Sponsor
- National Institute of Mental Health
- Modality
- Small Molecules
- Drugs
- levetiracetam
- Conditions
- bipolar disorder (BD)
01
Overview
Phase 2, open-label, single-arm trial of levetiracetam in bipolar disorder (BD), sponsored by National Institute of Mental Health. Primary endpoint: Clinical Global Impressions-Bipolar Version Response at 8 weeks. Started Apr 2001; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Levetiracetam Adjunctive
Levetiracetam added to current treatment.
03
Who it enrols
Patients with bipolar I, II, NOS, or schizoaffective disorder who have not responded to two standard treatments (lithium, valproate, carbamazepine, or neuroleptics).
04
Endpoints
Primary
Clinical Global Impressions-Bipolar Version Response
Secondary
Inventory of Depressive Symptomatology Score
Young Mania Rating Scale Score
NIMH Life Chart Method - Prospective
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