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The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression (Abilify)

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ClinicalTrials.gov Identifier: NCT00556140
Recruitment Status : Completed
First Posted : November 9, 2007
Results First Posted : August 20, 2012
Last Update Posted : August 20, 2012
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
John D. Matthews, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psychotic Depression
Intervention Drug: Aripiprazole
Enrollment 16
Recruitment Details Recruitment ran from Sept. 13, 2004 to Aug. 9, 2006 from the Massachusetts General Psychiatry Inpatient and Outpatient clinics.
Pre-assignment Details All participants enrolled in the study were given aripiprazole and escitalopram.
Arm/Group Title Major Depression With Psychotic Features
Hide 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
Arm/Group Title Major Depression With Psychotic Features
Hide 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 Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
16
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
41.8  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
6
  37.5%
Male
10
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Depression and Psychosis Response Rate
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percent of participants
62.5
2.Secondary Outcome
Title Depression and Psychosis Remission Rate
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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 Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percent of participants
50
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Major Depression With Psychotic Features
Hide 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 (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Major Depression With Psychotic Features
Affected / at Risk (%) # Events
Total   2/16 (12.50%)    
Psychiatric disorders   
worsening of major depression with psychotic features  [1]  1/16 (6.25%)  1
Vascular disorders   
Orthostatic hypotension  [2]  1/16 (6.25%)  1
Indicates events were collected by systematic assessment
[1]
1 subject had to be hospitalized for worsening of major depression with psychotic features.
[2]
1 subject had a severe orthostatic drop in her blood pressure requiring an ED visit while on aripiprazole 15mg a day, escitalopram 10 mg a day, and propanolol 10 mg 3 times a day.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Major Depression With Psychotic Features
Affected / at Risk (%) # Events
Total   16/16 (100.00%)    
Gastrointestinal disorders   
Gastrointestinal distress   4/16 (25.00%)  4
General disorders   
Fatigue   2/16 (12.50%)  2
Sedation   2/16 (12.50%)  2
Body aches   2/16 (12.50%)  2
Nervous system disorders   
Akathisia   10/16 (62.50%)  10
Indicates events were collected by systematic assessment
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. John Matthews
Organization: Massachusetts General Hospital
Phone: 617-724-0847
EMail: jmatthews@partners.org
Layout table for additonal information
Responsible Party: John D. Matthews, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00556140     History of Changes
Other Study ID Numbers: 2003-P-000990
First Submitted: November 8, 2007
First Posted: November 9, 2007
Results First Submitted: June 1, 2012
Results First Posted: August 20, 2012
Last Update Posted: August 20, 2012