Dawn F Ionescu1, Maurizio Fava2, Daniel Ju Hyung Kim3, Lee Baer1, Richard C Shelton4, Cristina Cusin1. 1. Massachusetts General Hospital, Depression Clinical and Research Program, Boston, MA, USA Harvard Medical School, Boston, MA. 2. Massachusetts General Hospital, Depression Clinical and Research Program, Harvard Medical School, 55 Fruit Street, Bulfinch 351, Boston, MA 02114, USA. 3. Massachusetts General Hospital, Depression Clinical and Research Program, Boston, MA, USA. 4. Department of Psychiatry, University of Alabama at Birmingham, Birmingham, AL, USA.
Abstract
BACKGROUND: Even when patients experience remission with antidepressants, many continue to report anger attacks and excessive irritability despite continued treatment. Iloperidone antagonizes 5-HT-2a, D2, and alpha-1 receptors, which can have anti-aggressive effects. We examined iloperidone's safety and efficacy as an augmentation agent in outpatients with partially remitted major depressive disorder (MDD) with residual symptoms of anger and irritability. METHODS: A total of 13 outpatients with partially remitted MDD [currently treated withselective serotonin reuptake inhibitors (SSRIs)] received four weeks of iloperidone or placebo, followed by one week of washout. Patients were then crossed over to the other treatment arm for 4 weeks. Treatment arms were randomized and double blind; and two sites were used for the study. Analyses compared treatment response using the Symptom Questionnaire (SQ) Anger/Hostility Subscale as the primary outcome measure. RESULTS: There was no significant differential effect of iloperidone × weeks on the SQ Anger/Hostility Subscore over the course of the study, compared with placebo × weeks, regardless of administration order (p = 0.77). CONCLUSIONS:Iloperidone did not significantly outperform placebo on measures of anger or irritability in patients with partially remitted MDD and residual anger/irritability.
RCT Entities:
BACKGROUND: Even when patients experience remission with antidepressants, many continue to report anger attacks and excessive irritability despite continued treatment. Iloperidone antagonizes 5-HT-2a, D2, and alpha-1 receptors, which can have anti-aggressive effects. We examined iloperidone's safety and efficacy as an augmentation agent in outpatients with partially remitted major depressive disorder (MDD) with residual symptoms of anger and irritability. METHODS: A total of 13 outpatients with partially remitted MDD [currently treated with selective serotonin reuptake inhibitors (SSRIs)] received four weeks of iloperidone or placebo, followed by one week of washout. Patients were then crossed over to the other treatment arm for 4 weeks. Treatment arms were randomized and double blind; and two sites were used for the study. Analyses compared treatment response using the Symptom Questionnaire (SQ) Anger/Hostility Subscale as the primary outcome measure. RESULTS: There was no significant differential effect of iloperidone × weeks on the SQ Anger/Hostility Subscore over the course of the study, compared with placebo × weeks, regardless of administration order (p = 0.77). CONCLUSIONS:Iloperidone did not significantly outperform placebo on measures of anger or irritability in patients with partially remitted MDD and residual anger/irritability.
Entities:
Keywords:
anger; augmentation; iloperidone; irritability; major depressive disorder
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