Efficacy of Combined Treatment for Young Bipolar I Disorder

Overview

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.

Full Title of Study: “Efficacy and Tolerability of the Combination of LIthium and CArbamazepine Compared to Lithium and VALproic Acid in the Treatment of Young Bipolar Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 2012

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: lithium plus carbamazepine
    • combination of the two drugs in standard dosage
  • Active Comparator: lithium plus valproate
    • combination of the two drugs in standard dosage

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: August 2012

Secondary Measures

  • 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
    • Time Frame: August 2012

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Sao Paulo
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ricardo Alberto Moreno, M.D., Ph.D., MD PhD – University of Sao Paulo

References

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. doi: 10.1016/j.jad.2005.01.004.

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