Clinical trial NCT00556140: The Combination of Aripiprazole and Antidepressants in 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psychotic Depression
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2007-11-09
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Depression and Psychosis Response Rate
timeFrame: Baseline and 7 weeks
Secondary outcomes:
measure: Depression and Psychosis Remission Rate
timeFrame: Baseline and 7 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Matthews D John, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.