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Completed

NCT Number: NCT00976794

Efficacy of Combined Treatment for Young Bipolar I Disorder

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.

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Key information

Conditions

Bipolar I Disorder

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Psychiatry - University of São Paulo

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lithium plus carbamazepine

Drug

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

Drug

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.

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Acronym: LICAVAL

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 14, 2009
Registry last updated
Jul 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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