The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression
Information source: Massachusetts General Hospital
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psychotic Depression
Intervention: Aripiprazole (Drug)
Phase: Phase 3
Sponsored by: Massachusetts General Hospital
Official(s) and/or principal investigator(s):
Matthews D John, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
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.
Official title: The Combination of Aripiprazole and Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants in the Acute Treatment of Psychotic Major Depression: Efficacy and Tolerability
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Depression and Psychosis Response Rate
Secondary outcome: Depression and Psychosis Remission Rate
Minimum age: 18 Years.
Maximum age: 80 Years.
1. Men and women aged 18-80 years, inclusive.
2. Drug-free outpatients or inpatients meeting DSM-IV criteria for major depression with
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.
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
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
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
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Starting date: June 2003
Last updated: July 11, 2012