Iloperidone Augmentation of SSRIs for Patients With Major Depressive Disorder With Residual Anger and Irritability
|ClinicalTrials.gov Identifier: NCT01464229|
Recruitment Status : Completed
First Posted : November 3, 2011
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Drug: Iloperidone Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Placebo-Controlled Crossover Study of Iloperidone Augmentation of SSRIs for Residual Anger and Irritability in Major Depressive Disorder|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
|Experimental: Iloperidone addition to SSRI antidepressant||
Iloperidone 1-8 mg for 4 weeks
|Placebo Comparator: Placebo addition to standard SSRI antidepressant||
- SQ Anger/Hostility Scale [ Time Frame: 9 weeks ]
Of the 20 patients randomized, data was analyzed for 13 completers. Symptom Questionnaire (SQ) Anger/Hostility Scale; this is a 23-item subscale of the 92-item Symptom Questionnaire.
This score ranges from 0 to 23; higher values represent higher anger and hostility.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01464229
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Maurizio Fava, MD||Massachusetts General Hospital|