Trial Outcomes & Findings for Abilify as an Adjunctive Treatment for Refractory Depression (NCT NCT00220636)

NCT ID: NCT00220636

Last Updated: 2016-05-26

Results Overview

Clinician rated measure of depression, mean score; this study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (\>50% decrease) Remission (score\<=7) Outcome is the number of these subjects whose depression "responded" after treatment with aripiprazole, which means a 50% or greater decrease in Hamilton Depression Rating Scale scores at week 12.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2016-05-26

Participant Flow

Participant milestones

Measure	Aripiprazole aripiprazole augmentation treatment
Overall Study STARTED	15
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Aripiprazole aripiprazole augmentation treatment
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Abilify as an Adjunctive Treatment for Refractory Depression

Baseline characteristics by cohort

Measure	Aripiprazole n=15 Participants aripiprazole augmentation treatment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	46 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Adults with treatment resistant depression, all subjects with data after baseline (14 of 15 subjects).

Clinician rated measure of depression, mean score; this study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) Outcome is the number of these subjects whose depression "responded" after treatment with aripiprazole, which means a 50% or greater decrease in Hamilton Depression Rating Scale scores at week 12.

Outcome measures

Measure	Aripiprazole n=14 Participants aripiprazole augmentation treatment
Hamilton Depression Rating Scale (HDRS)	7 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: all subjects for whom data was available after beginning aripiprazole augmentation (14 of 15 subjects)

clinician rated improvement, score on CGI scale ranging from 1 (very much improved) to 7 (very much worse)

Outcome measures

Measure	Aripiprazole n=14 Participants aripiprazole augmentation treatment
Clinical Global Impressions Improvement Scale (CGI)	2.8 units on CGI scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: All subjects (14/15) for whom data was available after starting aripiprazole augmentation

Ranging from 0 to 100, with higher score indicating better global functioning. Outcome is the post-treatment GAFS score compared to the pre-treatment GAFS score.

Outcome measures

Measure	Aripiprazole n=14 Participants aripiprazole augmentation treatment
Change in Global Assessment of Functioning Scale (GAFS)	7.3 points on GAFS scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: baseline and 12 weeks

Population: Number of participants for whom data was available after starting aripiprazole augmentation

21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.

Outcome is the subject's total BDI score post-treatment compared to the subject's total BDI score pre-treatment.

Outcome measures

Measure	Aripiprazole n=14 Participants aripiprazole augmentation treatment
Change in Beck Depression Inventory (BDI) Score	4.2 points on BDI scale Standard Deviation 10.0

Adverse Events

Aripiprazole

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Aripiprazole n=15 participants at risk aripiprazole augmentation treatment
Nervous system disorders fatigue	53.3% 8/15 • Number of events 15 • 16 weeks, during and after the clinical trial
Gastrointestinal disorders nausea	46.7% 7/15 • Number of events 15 • 16 weeks, during and after the clinical trial

Additional Information

David Hellerstein MD

NY State Psychiatric Institute

Phone: 6467748000

Email: hellers@nyspi.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place