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
This purpose of this study is to evaluate the safety and efficacy of Licarbazepine for the treatment of manic episodes of bipolar disorder.
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 :
August 1 2006
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT00099229
Start Date
November 1 2004
End Date
August 1 2006
Last Update
February 23 2017
Active Locations (22)
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1
Investigational Site
Little Rock, Arkansas, United States, 72211
2
Investigational Site
Cerritos, California, United States, 90703
3
Investigational Site
San Diego, California, United States, 92126
4
Investigational Site
Port Charlotte, Florida, United States, 33952