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NCT01464229 · ClinicalTrials.gov registry record · Phase 4

Iloperidone Augmentation of SSRIs for Patients With Major Depressive Disorder With Residual Anger and Irritability

A Phase 4 study, sponsored by Maurizio Fava, MD.

Completed
Registry status
Phase 4
Development phase
20
Enrollment target

NCT01464229 is a Phase 4 study that has completed, run by Maurizio Fava, MD. The registered enrollment target is 20 participants.

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The verdict

NCT01464229, a Phase 4 study, has completed, sponsored by Maurizio Fava, MD.

COMPLETED
Registry status
Phase 4
Development phase
20 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Iloperidone

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2012-04
Est. Completion 2014-12
Phase Phase 4

Sponsor

Maurizio Fava, MD

4 total trials

What the Registry Record Tells You About NCT01464229

The ClinicalTrials.gov registry entry for NCT01464229 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Maurizio Fava, MD, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01464229 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01464229 about?

NCT01464229 is a clinical study titled "Iloperidone Augmentation of SSRIs for Patients With Major Depressive Disorder With Residual Anger and Irritability". 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). T...

What is the current status of trial NCT01464229?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2012-04. Estimated completion is 2014-12.

What interventions are being tested in trial NCT01464229?

The interventions under investigation include: Placebo (DRUG), Iloperidone (DRUG).

Who is sponsoring clinical trial NCT01464229?

This trial is sponsored by Maurizio Fava, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.