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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01464229
First received: October 31, 2011
Last updated: November 4, 2014
Last verified: November 2014
  Purpose

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 Intervention Phase
Major Depressive Disorder
Drug: Iloperidone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Crossover Study of Iloperidone Augmentation of SSRIs for Residual Anger and Irritability in Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Total score on Anger/Hostility scale of the Symptom Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: April 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iloperidone addition to SSRI antidepressant Drug: Iloperidone
Iloperidone 1-8 mg for 4 weeks
Placebo Comparator: Placebo addition to standard SSRI antidepressant Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464229

Contacts
Contact: Daniel Ju Hyung Kim, BA 617-724-0586 djhkim@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Daniel Ju Hyung Kim, BA    617-724-0586    djhkim@partners.org   
Principal Investigator: Maurizio Fava, MD         
Sponsors and Collaborators
Maurizio Fava, MD
Novartis Pharmaceuticals
Investigators
Principal Investigator: Maurizio Fava, MD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Maurizio Fava, MD, Executive Vice Chair, Department of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01464229     History of Changes
Other Study ID Numbers: 2011P002043
Study First Received: October 31, 2011
Last Updated: November 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014