Status:
COMPLETED
Iloperidone Augmentation of SSRIs for Patients With Major Depressive Disorder With Residual Anger and Irritability
Lead Sponsor:
Maurizio Fava, MD
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01464229
Start Date
April 1 2012
End Date
December 1 2014
Last Update
April 11 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114