Efficacy of Combined Treatment for Young Bipolar I Disorder

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00976794

Acronym

LICAVAL

Enrollment

Registered

2009-09-14

Start date

2009-01-31

Completion date

2012-06-30

Last updated

2013-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar I Disorder

Keywords

BD I

Brief 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.

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

DRUGlithium 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

DRUGlithium 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

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

Design outcomes

Primary

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.	August 2012

Secondary

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	August 2012

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026