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The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression (Abilify)
This study is ongoing, but not recruiting participants.
First Received: November 8, 2007   No Changes Posted
Sponsor: Massachusetts General Hospital
Collaborator: Bristol-Myers Squibb
Information provided by: 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 III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Single Group Assignment
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:


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 ]

Enrollment: 35
Study Start Date: June 2003
Estimated Study Completion Date: January 2008
Arms Assigned Interventions
1: Experimental 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.

  Eligibility

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

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
  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/Harvard Medical School
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: 2003-P-000990
Study First Received: November 8, 2007
Last Updated: November 8, 2007
ClinicalTrials.gov Identifier: NCT00556140     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Affective Disorders, Psychotic
Mental Disorders
Therapeutic Uses
Psychotic Disorders
Aripiprazole
Antidepressive Agents
Schizophrenia and Disorders with Psychotic Features
Depression
Tranquilizing Agents
Bipolar Disorder
Central Nervous System Depressants
Depressive Disorder
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010