Status:
COMPLETED
Study of Licarbazepine in the Treatment of Manic Episodes of Bipolar Disorder
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief 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 a...
Eligibility Criteria
Inclusion
- Diagnosis of bipolar disorder (type I) with manic or mixed episodes (including patients with/without psychotic features or with/without a history of rapid cycling)
- In need of psychiatric treatment
- Cooperation and willingness to complete all aspects of the study
Exclusion
- Current diagnosis other than bipolar I disorder
- History of schizophrenia or schizoaffective disorder
- Drug dependence within 1 month prior to study start or testing positive in a urine drug test
- Suicide attempt within 1 month prior to study start or at immediate risk of harm to self or others
- Any form of psychotherapy within 1 month prior to study start
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
453 Patients enrolled
Trial Details
Trial ID
NCT00107939
Start Date
November 1 2004
End Date
April 1 2007
Last Update
March 22 2017
Active Locations (22)
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1
Investigational Site
Little Rock, Arkansas, United States, 72201
2
Investigational Site
Orange, California, United States, 92868
3
Investigational Site
Pico Rivera, California, United States, 90660
4
Investigational Site
San Diego, California, United States, 92108