An open label follow-up study on amisulpride in the add-on treatment of bipolar I patients.

Abstract

Background: Atypical antipsychotics are widely used in the treatment of bipolar disorders.Amisulpride is an atypical antipsychotic that has been proven to be effective in treatment ofschizophrenia, major depressive disorder and, more recently, acute mania. At the moment,however, no study has assessed the effectiveness of this compound in maintenance therapy ofbipolar disorders. The purpose of this study was to assess the long-term effectiveness ofamisulpride in combination with standard treatments in patients with bipolar I disorder who haveshown inadequate responses to ongoing standard therapies.Methods: The study enrolled fourteen bipolar I outpatients, not responding to ongoing standard therapy.Three patients discontinued treatment but 11 were followed-up for 11.7 ± 8.2 months before(range 3-24 months) and 5.2 ± 2.7 months after the introduction of amisulpride (range 3-9months). Relapse rates before and during treatment with amisulpride were calculated inaccordance to an increase of 1 or more in Clinical Global Impressions Scale-Bipolar Version (CGI-BP) score that was accompanied by a change in therapy or to an exacerbation of the symptomsthat required hospitalization.Results: A statistically significant decrease in overall relapse rate was observed during the periodof amisulpride therapy compared with months previous to the introduction of amisulpride. Therelative risk of relapse in the absence of amisulpride therapy was 3.1 (χ2 = 4.2, P < 0.05). Similarly,the rates of manic/mixed and depressive relapse were decreased but only manic episodes reachedstatistical significance (RR = 5.3, χ2 = 5.2, P < 0.02).Discussion and conclusion: This open-label study suggests that long-term therapy withamisulpride may benefit patients by improving global symptoms of bipolar disorder and reducingthe rate of manic/mixed relapses. Large, randomized, double-blind, placebo-controlled studies areneeded to explore the benefits of adding long-term amisulpride to standard therapies for bipolardisorder.Published: 24 August 2006Clinical Practice and Epidemiology in Mental Health 2006, 2:19doi:10.1186/1745-0179-2-19Received: 18 April 2006Accepted: 24 August 2006This article is available from: http://www.cpementalhealth.com/content/2/1/19© 2006 Carta et al; licensee BioMed Central Ltd.This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.