CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Iloperidone +1 moredrug
Likely dose
Iloperidone 8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01464229
NCT01464229Phase 4Completed

A Placebo-Controlled Crossover Study of Iloperidone Augmentation of SSRIs for Residual Anger and Irritability in Major Depressive Disorder

Maurizio Fava, MD·interventional·Posted Nov 3, 2011·Updated Apr 11, 2017

In Brief

A Phase 4 clinical trial evaluating Iloperidone and Placebo for Major Depressive Disorder. Completed, enrolled 20 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 3, 2011
Enrollment StartApr 1, 2012
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.7 years ago

Interventions

Iloperidonedrug

Iloperidone 1-8 mg for 4 weeks

Placebodrug

Placebo