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

NCT01464229 | Completed Phase 4 Results DMC

• 1 other identifier: 2011P002043
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  9 weeks

Study Arms (2)

Iloperidone addition to SSRI antidepressant

EXPERIMENTAL

Drug: Iloperidone

Placebo addition to standard SSRI antidepressant

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Iloperidone DRUG

Iloperidone 1-8 mg for 4 weeks

Iloperidone addition to SSRI antidepressant

Placebo DRUG

Placebo

Placebo addition to standard SSRI antidepressant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Maurizio Fava, MD: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 26913173 RESULT

Related Links

• Massachusetts General Hospital Depression Clinical and Research Program Website

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

iloperidone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Esther Howe
• Organization: MGH

ehowe3@partners.org

617-726-8895

Study Officials

• Maurizio Fava, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Vice Chair, Department of Psychiatry

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 3, 2011
• Study Start: April 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 11, 2017
• Results First Posted: April 11, 2017

Record last verified: 2017-02

Locations

US (1)