Trial Outcomes & Findings for The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression (NCT NCT00556140)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

16 participants

Primary outcome timeframe

Baseline and 7 weeks

Results posted on

2012-08-20

Participant Flow

Recruitment ran from Sept. 13, 2004 to Aug. 9, 2006 from the Massachusetts General Psychiatry Inpatient and Outpatient clinics.

All participants enrolled in the study were given aripiprazole and escitalopram.

Participant milestones

Participant milestones
Measure	Major Depression With Psychotic Features 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 Study STARTED	16
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Combination of Aripiprazole and Antidepressants in Psychotic Major Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Major Depression With Psychotic Features n=16 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	41.8 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 7 weeks

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

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.

Outcome measures

Outcome measures
Measure	Major Depression With Psychotic Features n=16 Participants 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.
Depression and Psychosis Response Rate	62.5 percent of participants 8.3

SECONDARY outcome

Timeframe: Baseline and 7 weeks

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

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.

Outcome measures

Outcome measures
Measure	Major Depression With Psychotic Features n=16 Participants 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.
Depression and Psychosis Remission Rate	50 percent of participants

Adverse Events

Major Depression With Psychotic Features

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Major Depression With Psychotic Features n=16 participants at risk 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.
Vascular disorders Orthostatic hypotension	6.2% 1/16 • Number of events 1
Psychiatric disorders worsening of major depression with psychotic features	6.2% 1/16 • Number of events 1

Other adverse events

Other adverse events
Measure	Major Depression With Psychotic Features n=16 participants at risk 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.
Nervous system disorders Akathisia	62.5% 10/16 • Number of events 10
Gastrointestinal disorders Gastrointestinal distress	25.0% 4/16 • Number of events 4
General disorders Fatigue	12.5% 2/16 • Number of events 2
General disorders Sedation	12.5% 2/16 • Number of events 2
General disorders Body aches	12.5% 2/16 • Number of events 2

Additional Information

Dr. John Matthews

Massachusetts General Hospital

Phone: 617-724-0847

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place