Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2010 Jun 23:11:72.
doi: 10.1186/1745-6215-11-72.

LICAVAL: combination therapy in acute and maintenance treatment of bipolar disorder

Rodolfo N Campos  1 , Luis F Costa, Danielle S Bio, Márcio G Soeiro de Souza, Carla R L Garcia, Frederico N Demétrio, Doris H Moreno, Ricardo A Moreno
Affiliations
Randomized Controlled Trial

LICAVAL: combination therapy in acute and maintenance treatment of bipolar disorder

Rodolfo N Campos et al. Trials. .

Abstract

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.

Trial registration: ClinicalTrials.gov Identifier: NCT00976794.

PubMed Disclaimer

Similar articles

See all similar articles

Cited by

References

    1. Goldberg JF. Optimizing treatment outcomes in bipolar disorder under ordinary conditions. J Clin Psychiatry. 2008;69(Suppl 3):11–9. - PubMed
    1. American Psychiatric Association. Text Revision. Fourth. Washington DC, American Psychiatric Association; 2000. Diagnostic and Statistical Manual of Mental Disorders.
    1. Beyer JL. An evidence-based medicine strategy for achieving remission in bipolar disorder. J Clin Psychiatry. 2008;69(Suppl 3):31–7. - PubMed
    1. Perlis RH, Ostacher MJ, Patel JK, Marangell LB, Zhang H, Wisniewski SR, Ketter TA, Miklowitz DJ, Otto MW, Gyulai L, Reilly-Harrington NA, Nierenberg AA, Sachs GS, Thase ME. Predictors of recurrence in bipolar disorder: primary outcomes from the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) Am J Psychiatry. 2006;163(2):217–24. doi: 10.1176/appi.ajp.163.2.217. - DOI - PubMed
    1. Goodwin FK. Rationale for long-term treatment of bipolar disorder and evidence for long-term lithium treatment. J Clin Psychiatry. 2002;63(Suppl 10):5–12. - PubMed

Publication types

Associated data