Efficacy of Risperidone Augmentation to Antidepressants in the Management of Suicidality in Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Pilot Study
J Clin Psychiatry 2008;69(8):1228-1236
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Objective: Major depressive disorder (MDD) is
a severe mental illness with high risk of
suicidality. Antidepressant treatment alone is not sufficient
for the acute management of risk-taking symptoms
of depression. This pilot study was designed to
investigate the efficacy of risperidone augmentation to
antidepressants in the acute management of
suicidality and other core symptoms in MDD with suicidality.
Method: Twenty-four adult men and women
diagnosed with MDD (DSM-IV), having a depressive episode with suicidality despite taking an
antidepressant, were enrolled in an 8-week
double-blind, placebo-controlled study. Subjects were
randomly assigned to receive risperidone (0.25-2 mg/day)
or placebo while continuing on their
antidepressant therapy. Clinical efficacy in suicidality,
depressive symptoms, and impulsivity were assessed after
treatment with study drugs for 4 days, weekly for
4 weeks, then every other week for 4 weeks.
Adverse events were also recorded at each visit. The
study was conducted from June 2004 to April 2007.
Results: Risperidone significantly reduced
suicidal ideations in MDD patients, and the overall
effect of risperidone appeared to be superior to
placebo. The effect of risperidone was rapid, with
onset at 2 weeks' treatment, and was sustained along
the course of 8 weeks' treatment. Furthermore,
risperidone demonstrated superiority to placebo in
improving other symptoms related to suicidality and
having better trial completion rate, and the low dose
risperidone was well tolerated by subjects in this study.
Conclusion: Data from this pilot study
suggest that risperidone is beneficial as an augmenting
treatment in MDD patients who have developed
high-risk suicidal ideation during a depressive episode.
The antisuicidality effect of risperidone is
especially valuable in the acute management of severe
depressive symptoms. Although the pilot study is limited
by small sample size, the promising results warrant
further larger scale investigation in the efficacy of
atypical antipsychotics in the treatment of severe
depression with suicidality.
Trial Registration: clinicaltrials.gov Identifier: NCT00167154