NCT00976794

Efficacy of Combined Treatment for Young Bipolar I Disorder

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	lithium plus carbamazepine	Lithium: Starting at 600 mg daily, dose weekly adjusted according to blood serum level (0,6 -1,2mEq/l), efficacy and tolerability. Carbamazepine : Starting at 200mg daily and getting 600 mg daily at the end of the first week. Dose weekly adjusted according to blood serum level (8 and 12µg/ml), efficacy and tolerability
DRUG	lithium plus valproate	Lithium: Starting at 600 mg daily, dose weekly adjusted according to blood serum level (0,6 -1,2mEq/l), efficacy and tolerability. Valproic acid: Starting at 500mg daily, dose weekly adjusted according to blood serum level (50 and 125µg/ml), efficacy and tolerability.

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2009-09-14
• Last updated: 2013-07-12

Locations

1 site across 1 country: Brazil