Efficacy of Combined Treatment for Young Bipolar I Disorder

Bipolar I Disorder Clinical Trial

— LICAVAL  

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 Details — Status: Completed

Administrative data

• NCT number: NCT00976794
• Other study ID #: 2898
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2009
• Last updated: July 10, 2013
• Start date: January 2009
• Est. completion date: June 2012

Study information

• Verified date: July 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Bipolar I Disorder

Intervention

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
• 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.

Locations

Country	Name	City	State
Brazil	Institute of Psychiatry - University of São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No