LICAVAL: combination therapy in acute and maintenance treatment of bipolar disorder.
BACKGROUND
The challenge of Bipolar Disorder (BD) treatment is due to the complexity of the disease. Current guidelines represent an effort to help clinicians in their everyday practice but still have limitations, specially concerning to long term treatment. LICAVAL (efficacy and tolerability of the combination of LIthium and CArbamazepine compared to lithium and VALproic acid in the treatment of young bipolar patients) study aim to evaluate acute and maintenance phase of BD treatment with two combined drugs.


METHODS
LICAVAL is a single site, parallel group, randomized, outcome assessor blinded trial. BD I patients according to the DSM-IV-TR, in depressive, manic,/hypomanic or mixed episode, aged 18 to 35 years are eligible. After the diagnostic assessments, the patients are allocated for one of the groups of treatment (lithium + valproic acid or 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). Outcome assessors are blind to the treatment. The main outcome is the evaluation of changes in mean scores on CGI-BP-M between baseline and endpoint at the end of each phase of the study.


RESULTS
LICAVAL is currently in progress, with patients in phase I, II or III. It will extended until august 2012.


CONCLUSIONS
Trials comparing specific treatments efficacy in BD (head to head) can show relevant information in clinical practice. Long term treatment is an issue of great important and should be evaluated carefully in more studies as long as BD is a chronic disease.


BACKGROUND
ClinicalTrials.gov Identifier: NCT00976794.
Campos
Rodolfo N
RN
Department and Institute of Psychiatry, Clinical Hospital, University of Sao Paulo, School of Medicine, Sao Paulo, Brazil.
Costa
Luis F
LF
Bio
Danielle S
DS
Soeiro de Souza
Márcio G
MG
Garcia
Carla R L
CR
Demétrio
Frederico N
FN
Moreno
Doris H
DH
Moreno
Ricardo A
RA
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D018692:Antimanic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001714:Bipolar Disorder / Q000188:drug therapy*; D002220:Carbamazepine / Q000008:administration & dosage* / Q000009:adverse effects; D003071:Cognition / Q000187:drug effects; D004359:Drug Therapy, Combination; D006801:Humans; D016651:Lithium Carbonate / Q000008:administration & dosage* / Q000009:adverse effects; D011788:Quality of Life; D012919:Social Behavior; D014635:Valproic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
D018692:Antimanic Agents; D016651:Lithium Carbonate; D002220:Carbamazepine; D014635:Valproic Acid