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Efficacy of Combined Treatment for Young Bipolar I Disorder

Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar I Disorder

Intervention: lithium plus carbamazepine (Drug); lithium plus valproate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Sao Paulo


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 Details

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

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

Primary outcome: 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.

Secondary outcome: 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

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.


Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Both.


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

Locations and Contacts

Institute of Psychiatry - University of São Paulo, Sao Paulo, Brazil
Additional Information

Related publications:

Fountoulakis KN, Vieta E, Sanchez-Moreno J, Kaprinis SG, Goikolea JM, Kaprinis GS. Treatment guidelines for bipolar disorder: a critical review. J Affect Disord. 2005 May;86(1):1-10. Review.

Starting date: January 2009
Last updated: July 10, 2013

Page last updated: August 23, 2015

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