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

University of Sao Paulo

Status and phase: Completed; Phase 4

Conditions: Bipolar I Disorder

Treatments: Drug: lithium plus valproate; Drug: lithium plus carbamazepine

Study type: Interventional

Funder types: Other

Identifiers

NCT00976794

2898

Details and patient eligibility

About

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 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

lithium plus carbamazepine

Experimental group

Description:

combination of the two drugs in standard dosage

Treatment:

Drug: lithium plus carbamazepine

lithium plus valproate

Active Comparator group

Description:

combination of the two drugs in standard dosage

Treatment:

Drug: lithium plus valproate