The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression

Phase 3

Completed

• Conditions: Psychotic Depression
• Interventions: Drug: Aripiprazole

• Registration Number: NCT00556140
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2007-11-08
• Study First Submitted QC: 2007-11-08
• Study First Posted: 2007-11-09
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2012-06-01
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-11
• Last Update Submitted: 2012-07-11
• Results First Posted: 2012-08-20
• Last Update Posted: 2012-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Major Depression with Psychotic Features	Aripiprazole	-

Primary Outcome Measures

Name	Time	Method
Depression and Psychosis Response Rate	Baseline and 7 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Depression and Psychosis Remission Rate	Baseline and 7 weeks	This remission rate refers to a Hamilton Depression Rating Scale 17 (HAM-D-17) score of 7 or less 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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States