Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
NCT00107926 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 343
Last updated 2017-03-22
Summary
The purpose of this study is to evaluate the effectiveness and tolerability of an investigational drug for the treatment of manic episodes of bipolar disorder. The investigational drug will be given as additional treatment with either lithium or valproate, which are already FDA (Food and Drug Administration)-approved treatments for mania.
Conditions
Interventions
- DRUG
-
Licarbazepine
- DRUG
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-10-31
- Primary Completion
- 2007-08-31
- Completion
- 2007-08-31
Countries
- United States
- Austria
- Canada
- Colombia
- Czechia
- Germany
- Guatemala
- Peru
- Russia
- Slovakia
- South Africa
- Ukraine
- Venezuela
Study Locations
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