Abilify: The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00556140
• Collaborator: Bristol-Myers Squibb (Industry)
• Enrollment: 16
• Location: 1
• Arm: 1
• Duration (Months): 55
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Psychotic Depression	Drug: Aripiprazole	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jun 1, 2003
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Major Depression with Psychotic Features

Drug: Aripiprazole; 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.; Other Names: Abilify

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John D. Matthews, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00556140
• Other Study ID Numbers: 2003-P-000990
• First Posted: Nov 9, 2007
• Last Update Posted: Aug 20, 2012
• Last Verified: Jul 1, 2012

• Additional relevant MeSH terms: Depression; Depressive Disorder; Mental Disorders; Psychotic Disorders; Aripiprazole

Study Results

Participant Flow

Recruitment Details	Recruitment ran from Sept. 13, 2004 to Aug. 9, 2006 from the Massachusetts General Psychiatry Inpatient and Outpatient clinics.
Pre-assignment Detail	All participants enrolled in the study were given aripiprazole and escitalopram.

Arm/Group Title	Major Depression With Psychotic Features
Arm/Group Description	All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
Period Title: Overall Study
STARTED	16
COMPLETED	13
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Major Depression With Psychotic Features
Arm/Group Description	All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
Overall Participants	16
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	16 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.8 (12.9)
Sex: Female, Male (Count of Participants)
Female	6 37.5%
Male	10 62.5%
Region of Enrollment (participants) [Number]
United States	16 100%

Outcome Measures

1. Primary Outcome

Title	Depression and Psychosis Response Rate
Description	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.
Time Frame	Baseline and 7 weeks

Outcome Measure Data

Analysis Population Description

For the 3 participants who did not complete the study, the "last observation carried forward" technique was used to replace missing data for them.

Arm/Group Title	Major Depression With Psychotic Features
Arm/Group Description	All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
Measure Participants	16
Number [percent of participants]	62.5 (8.3) 390.6%

2. Secondary Outcome

Title	Depression and Psychosis Remission Rate
Description	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.
Time Frame	Baseline and 7 weeks

Outcome Measure Data

Analysis Population Description

For the 3 participants who did not complete the study, the "last observation carried forward" technique was used to replace missing data for them.

Arm/Group Title	Major Depression With Psychotic Features
Arm/Group Description	All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
Measure Participants	16
Number [percent of participants]	50 312.5%

Adverse Events

Arm/Group Title	Major Depression With Psychotic Features
Arm/Group Description	All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
All Cause Mortality
	Major Depression With Psychotic Features
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Major Depression With Psychotic Features
	Affected / at Risk (%)	# Events
Total	2/16 (12.5%)
Psychiatric disorders
worsening of major depression with psychotic features	1/16 (6.3%)	1
Vascular disorders
Orthostatic hypotension	1/16 (6.3%)	1
Other (Not Including Serious) Adverse Events
	Major Depression With Psychotic Features
	Affected / at Risk (%)	# Events
Total	16/16 (100%)
Gastrointestinal disorders
Gastrointestinal distress	4/16 (25%)	4
General disorders
Fatigue	2/16 (12.5%)	2
Sedation	2/16 (12.5%)	2
Body aches	2/16 (12.5%)	2
Nervous system disorders
Akathisia	10/16 (62.5%)	10

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.