The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression (Abilify)

The Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants in the Acute Treatment of Psychotic Major Depression: Efficacy and Tolerability

The purpose of the study is to assess the safety and effectiveness of the combination of aripiprazole (Abilify) and selective serotonin reuptake inhibitors (SSRIs) in subjects with psychotic major depression.

Study Overview

• Status: Completed
• Conditions: Psychotic Depression
• Intervention / Treatment: Drug: Aripiprazole

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men and women aged 18-80 years, inclusive.
2. Drug-free outpatients or inpatients meeting DSM-IV criteria for major depression with psychotic features.
3. Inpatients who undergo a 5-7 day washout period of their medication while concurrently beginning one of the approved SSRI's and abilify.
4. HAM-D-24 score > 16.

Exclusion Criteria:

1. Pregnant women and women of child bearing potential not using a medically accepted means of contraception (oral contraceptives are allowed).
2. Women who are breast-feeding.
3. Patients meeting DSM-IV criteria for major depression without psychotic features, or psychosis without major depression at the screen visit.
4. Patients with serious suicidal risk.
5. Patients with a history of seizure disorder; unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic); or any physical disorder judged to significantly affect central nervous system function.
6. Patients meeting criteria for the following DSM-IV diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last 6 months; bipolar disorder; schizoaffective disorder; or antisocial personality disorder.
7. Patients who are currently taking an antidepressant, antipsychotic, or mood stabilizing drug and who are responding to one or all of these medications. If patients are not responding to these medications, they may go through a washout period of at least one week under the supervision of a study doctor before entering into this study.
8. Patients who are not able to read and understand the consent form, or who are not capable of understanding or giving informed consent to the procedures of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Major Depression with Psychotic Features

Drug: Aripiprazole; Everyone in this study will receive aripiprazole and an antidepressant called a selective serotonin reuptake inhibitor (SSRI). There is only one arm for this study. Aripiprazole is an antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia. You will receive aripiprazole (Abilify) and one of the following SSRI antidepressant medications that will be determined by the study doctor and you: sertraline (Zoloft), citalapram (Celexa), or escitalopram (Lexapro). The dose of aripiprazole (Abilify) will be 10 milligrams a day, and the starting doses for the SSRI anti-depressants will be: sertraline (Zoloft) 50 milligrams a day, citalopram (Celexa) 20 milligrams a day, and escitalopram (Lexapro) 10 milligrams a day.; Other Names: Abilify

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression and Psychosis Response Rate	This response rate refers to the percentage of patients who experienced a 50 percent or greater reduction in symptoms. Specifically, this refers to a 50 percent reduction in Hamilton Depression Rating Scale 17 (HAM-D-17) scores from baseline and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed.	Baseline and 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression and Psychosis Remission Rate	This remission rate refers to a Hamilton Depression Rating Scale 17 (HAM-D-17) score of 7 or less and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed.	Baseline and 7 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Matthews D John, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Matthews JD, Siefert C, Dording C, Denninger JW, Park L, van Nieuwenhuizen AO, Sklarsky K, Hilliker S, Homberger C, Rooney K, Fava M. An open study of aripiprazole and escitalopram for psychotic major depressive disorder. J Clin Psychopharmacol. 2009 Feb;29(1):73-6. doi: 10.1097/JCP.0b013e318193dfb4.

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: November 8, 2007
• First Submitted That Met QC Criteria: November 8, 2007
• First Posted (Estimate): November 9, 2007

Study Record Updates

• Last Update Posted (Estimate): August 20, 2012
• Last Update Submitted That Met QC Criteria: July 11, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Depression; Depressive Disorder; Psychotic Disorders; Mental Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: 2003-P-000990