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

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Iloperidone

Placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent.
Men or women ages 18-65 years old.
Current Major Depressive Episode in partial remission based on the Structured Clinical Interview for DSM IV-Axis I Disorders (SCID I/P) and a HAM-D-17 score between 9 and 15.
Current treatment with a selective serotonin reuptake inhibitor (SSRI) other than paroxetine or fluoxetine for at least three months, at a stable dose for the past 4 weeks, and more than 50% but less than 75% improvement on the current antidepressant, as determined by the MGH Antidepressant Treatment Response Questionnaire (ATRQ).
Score > 8 on the Anger/Hostility Scale of the Symptom Questionnaire both at screen and baseline.

Exclusion Criteria:

The following DSM-IV diagnoses: 1) organic mental disorders; 2) substance use disorders, including alcohol, active within the last 3 months; 3) schizophrenia; 4) delusional disorder; 5) psychotic disorders not elsewhere classified; 6) bipolar disorder; and 9) antisocial personality disorder; 10) dementia.
Current, serious suicidal or homicidal risk.
Pregnancy or breast-feeding.
Serious, unstable medical illness including cardiovascular, kidney, liver, neurological and endocrine disorders.
Congenital long QT syndrome or a QTc > 450 ms.
History of cardiac arrhythmias.
Electroconvulsive therapy (ECT) within the 6 months preceding baseline.
Concomitant use of buspirone, fluoxetine, paroxetine, any psychostimulant, modafinil, other antipsychotic drugs, or anticonvulsants (although stable doses of benzodiazepines and hypnotics are allowed) (see Concomitant Therapy).

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Iloperidone addition to SSRI antidepressant

Placebo addition to standard SSRI antidepressant

Arm Description

Outcomes

Primary Outcome Measures

SQ Anger/Hostility Scale

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01464229

First Posted

October 31, 2011

Last Updated

February 28, 2017

Sponsor

Maurizio Fava, MD

Collaborators

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01464229

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Maurizio Fava, MD

Collaborators

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Iloperidone addition to SSRI antidepressant

Arm Type

Experimental

Arm Title

Placebo addition to standard SSRI antidepressant

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Iloperidone

Intervention Description

Iloperidone 1-8 mg for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

SQ Anger/Hostility Scale

Description

Time Frame

9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent. Men or women ages 18-65 years old. Current Major Depressive Episode in partial remission based on the Structured Clinical Interview for DSM IV-Axis I Disorders (SCID I/P) and a HAM-D-17 score between 9 and 15. Current treatment with a selective serotonin reuptake inhibitor (SSRI) other than paroxetine or fluoxetine for at least three months, at a stable dose for the past 4 weeks, and more than 50% but less than 75% improvement on the current antidepressant, as determined by the MGH Antidepressant Treatment Response Questionnaire (ATRQ). Score > 8 on the Anger/Hostility Scale of the Symptom Questionnaire both at screen and baseline. Exclusion Criteria: The following DSM-IV diagnoses: 1) organic mental disorders; 2) substance use disorders, including alcohol, active within the last 3 months; 3) schizophrenia; 4) delusional disorder; 5) psychotic disorders not elsewhere classified; 6) bipolar disorder; and 9) antisocial personality disorder; 10) dementia. Current, serious suicidal or homicidal risk. Pregnancy or breast-feeding. Serious, unstable medical illness including cardiovascular, kidney, liver, neurological and endocrine disorders. Congenital long QT syndrome or a QTc > 450 ms. History of cardiac arrhythmias. Electroconvulsive therapy (ECT) within the 6 months preceding baseline. Concomitant use of buspirone, fluoxetine, paroxetine, any psychostimulant, modafinil, other antipsychotic drugs, or anticonvulsants (although stable doses of benzodiazepines and hypnotics are allowed) (see Concomitant Therapy).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maurizio Fava, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26913173

Citation

Ionescu DF, Fava M, Kim DJ, Baer L, Shelton RC, Cusin C. A placebo-controlled crossover study of iloperidone augmentation for residual anger and irritability in major depressive disorder. Ther Adv Psychopharmacol. 2016 Feb;6(1):4-12. doi: 10.1177/2045125315618621.

Results Reference

result

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

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