The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression - Full Text View

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

This study has been completed.

First Received on November 8, 2007. Last Updated on May 2, 2012 History of Changes

Sponsor:	Massachusetts General Hospital
Collaborator:	Bristol-Myers Squibb
Information provided by (Responsible Party):	John D. Matthews, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00556140

Purpose

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.

Condition	Intervention	Phase
Psychotic Depression	Drug: Aripiprazole	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants in the Acute Treatment of Psychotic Major Depression: Efficacy and Tolerability

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression Mental Disorders Psychotic Disorders

Drug Information available for: Serotonin Aripiprazole

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

assess the safety and efficacy of the combination of aripiprazole and SSRI in patients with psychotic major depression. [ Time Frame: study duration ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	June 2003
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Aripiprazole 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: 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 Name: Abilify

Arms

Assigned Interventions

Experimental: 1

Drug: Aripiprazole

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: 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 Name: Abilify

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant women and women of child bearing potential not using a medically accepted means of contraception (oral contraceptives are allowed).
Women who are breast-feeding.
Patients meeting DSM-IV criteria for major depression without psychotic features, or psychosis without major depression at the screen visit.
Patients with serious suicidal risk.
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.
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.
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.
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556140

Locations

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

Sponsors and Collaborators

Massachusetts General Hospital

Bristol-Myers Squibb

Investigators

Principal Investigator:

Matthews D John, MD

Massachusetts General Hospital

More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	John D. Matthews, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00556140 History of Changes
Other Study ID Numbers:	2003-P-000990
Study First Received:	November 8, 2007
Last Updated:	May 2, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Depression
Depressive Disorder
Mental Disorders
Psychotic Disorders
Depressive Disorder, Major
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Affective Disorders, Psychotic
Antidepressive Agents
Serotonin Uptake Inhibitors
Aripiprazole

Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 24, 2012