Efficacy of Combined Treatment for Young Bipolar I Disorder

Phase 4

Completed

• Conditions: Bipolar I Disorder
• Interventions: Drug: lithium plus carbamazepine; Drug: lithium plus valproate

• Registration Number: NCT00976794
• Lead Sponsor: University of Sao Paulo

Brief 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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2009-09-11
• Study First Posted: 2009-09-14
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-10
• Last Update Posted: 2013-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Clinical diagnosis of Bipolar Disorder, type I, in current episode (manic/hypomanic, mixed or depression)
• The patient or his (her) legal representative should understand the nature of the study and sign the Informed Consent.

Exclusion Criteria

• Schizophrenia or schizoaffective disorder
• Mental retardation
• Unstable clinical diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lithium plus carbamazepine	lithium plus carbamazepine	combination of the two drugs in standard dosage
lithium plus valproate	lithium plus valproate	combination of the two drugs in standard dosage

Primary Outcome Measures

Name	Time	Method
The main outcome will be the number of patients that achieve and remain in remission to each treatment at the end of each phase of the study.	August 2012

Secondary Outcome Measures

Name	Time	Method
Secondary outcome will include the proportion of patients that had response but not remission to each treatment at the end of each phase of the study	August 2012

Trial Locations

Locations (1)

Institute of Psychiatry - University of São Paulo; 🇧🇷 Sao Paulo, Brazil