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Efficacy of Combined Treatment for Young Bipolar I Disorder — LICAVAL  

Bipolar I Disorder Clinical Trial

Official title:
Efficacy and Tolerability of the Combination of LIthium and CArbamazepine Compared to Lithium and VALproic Acid in the Treatment of Young Bipolar Patients

Clinical Trial Summary

The purpose of this study is to determine the efficacy of the combination of lithium and carbamazepine compared with lithium and valproate treating young bipolar patients.

Clinical Trial Description

After the diagnostic assessments, the patients are allocated for one of the following groups of treatment:

Group I: lithium + valproic acid

Group II: lithium + carbamazepine

Patients will be followed up for 8 weeks in phase I (acute treatment), 6 months in phase II (continuation treatment) and 12 months in phase III (maintenance treatment). Scales raters will be blind to the treatment.

During phase II and III will continue only patients that achieve response, measured according to initial symptoms score in phase I. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00976794
Study type Interventional
Source University of Sao Paulo
Contact
Status Completed
Phase Phase 4
Start date January 2009
Completion date June 2012
View Details
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