Major Depressive Disorder Clinical Trial
Official title:
A Placebo-Controlled Crossover Study of Iloperidone Augmentation of SSRIs for Residual Anger and Irritability in Major Depressive Disorder
Iloperidone is an atypical antipsychotic drug, FDA-approved for the acute treatment of
schizophrenia in adults in 2009 (Marino et al., 2010); moreover, some of its pharmacological
features seem to be very promising in treating symptoms like anger and anxiety (Fava et al.,
1997; Wang et al., 2010). The investigators therefore feel that an adequately sized, well
powered, double-blind, placebo-controlled, randomized, cross-over study of iloperidone
augmentation of SSRIs among MDD outpatients in partial remission with residual anger and
irritability is warranted at this point to evaluate its efficacy, safety and tolerability on
residual anger, irritability and depressive symptoms.
Main hypothesis: Adults with MDD in partial remission, who are experiencing residual
symptoms of anger and irritability, assigned to treatment with iloperidone will demonstrate
a significantly greater reduction in the total score of the Anger/Hostility Scale of the
Symptom Questionnaire from baseline to endpoint than those assigned to placebo using the
cross-over design.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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