Efficacy of Combined Treatment for Young Bipolar I Disorder (LICAVAL)

July 10, 2013 updated by: Ricardo Alberto Moreno, M.D., Ph.D., University of Sao Paulo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil
        • Institute of Psychiatry - University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lithium plus carbamazepine
combination of the two drugs in standard dosage
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
Active Comparator: lithium plus valproate
combination of the two drugs in standard dosage
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
August 2012

Secondary Outcome Measures

Outcome Measure
Time Frame
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
August 2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

September 11, 2009

First Posted (Estimate)

September 14, 2009

Study Record Updates

Last Update Posted (Estimate)

July 12, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2898

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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