The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression

NCT00556140 | Completed Phase 3 Results

• 1 other identifier: 2003-P-000990
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Depression and Psychosis Remission Rate

  Baseline and 7 weeks

Study Arms (1)

Major Depression with Psychotic Features

EXPERIMENTAL

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

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.

Also known as: Abilify

Major Depression with Psychotic Features

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 19142112 DERIVED

MeSH Terms

Interventions

Aripiprazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

We had several limitations to the study. The sample size was small, and we used an open and uncontrolled study design. We also excluded subjects who currently or recently abused alcohol, recreational drugs, and/or prescription drugs.

Results Point of Contact

• Title: Dr. John Matthews
• Organization: Massachusetts General Hospital

jmatthews@partners.org

617-724-0847

Study Officials

• Matthews D John, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 9, 2007
• Study Start: June 1, 2003
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: August 20, 2012
• Results First Posted: August 20, 2012

Record last verified: 2012-07

Locations

US (1)