%0 Journal Article
%T Analysis of suicidality in pooled data from 2 double-blind, placebo-controlled aripiprazole adjunctive therapy trials in major depressive disorder
%J Journal of clinical psychiatry
%D 2011
%A Weisler, R. H.
%A Khan, A.
%A Trivedi, Madhukar H.
%A Yang, Hsuanchih
%A Eudicone, J. M.
%A Pikalov, A.
%A Tran, Q. V.
%A Berman, R. M.
%A Carlson, B. X.
%V 72
%N 4
%P 548-555
%X OBJECTIVE: To assess the impact of adjunctive aripiprazole versus adjunctive placebo treatment on suicidality in patients with major depressive disorder. METHOD: Data were pooled from 2 identical aripiprazole augmentation studies. Patients with DSM-IV-TR-diagnosed major depressive disorder with an inadequate response to 8 weeks of prospective antidepressant treatment were randomly assigned to adjunctive placebo or adjunctive aripiprazole (2-20 mg/d) treatment for 6 weeks. Adverse events related to suicidality were identified in the adverse event database using the Medical Dictionary for Regulatory Activities-preferred term. Treatment-emergent suicidal ideation was defined using item 10 (suicidality) of the Montgomery-Asberg Depression Rating Scale (MADRS) and item 18 (suicidality) of the Inventory of Depressive Symptomatology (IDS). RESULTS: In total, 737 patients were included in the safety database (aripiprazole n=371; placebo n=366). No suicides were reported. There were no treatment-emergent, suicide-related adverse events in the aripiprazole group; 2 patients in the placebo group had>/=1 adverse event related to suicide (both suicidal ideation). More placebo than aripiprazole patients>25 years old experienced a 2-point (P<.01) or 1-point (P<.05) worsening of MADRS item 10 scores. For this age group, 2-point improvement in MADRS item 10 scores and 1-point improvement of IDS item 18 scores were significantly more common in aripiprazole patients than placebo patients (both P<.05). CONCLUSIONS: This post hoc analysis demonstrated that adjunctive aripiprazole treatment in patients with depression with a history of an inadequate response to antidepressant medication is associated with a decreased rate of suicidality in a group of subjects not at significant risk. Prospective trials directly assessing suicidality are needed to further understand the benefits of an adjunctive antipsychotic in an at-risk population. TRIAL REGISTRATION: clinicaltrials.gov Identifiers: NCT00095823 and NCT00095758.<p /> <p>Language: en</p>
%G en
%I Physicians Postgraduate Press
%@ 0160-6689
%U http://dx.doi.org/10.4088/JCP.09m05495gre