Trial Outcomes & Findings for Buprenorphine for Treatment Resistant Depression (NCT NCT01407575)

Results Overview

measure of depression severity Theoretical Range 0-60 lower values represent better outcome

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

13 participants

Primary outcome timeframe

6 weeks

Results posted on

2018-03-09

Participant Flow

Participant milestones

Participant milestones
Measure	Buprenorphine Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)	Placebo Placebo: matched placebo
Overall Study STARTED	7	6
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Buprenorphine for Treatment Resistant Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Buprenorphine n=7 Participants Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)	Placebo n=6 Participants Placebo: matched placebo	Total n=13 Participants Total of all reporting groups
Age, Continuous	53.92 years STANDARD_DEVIATION 15.88 • n=39 Participants	64.59 years STANDARD_DEVIATION 5.01 • n=41 Participants	59.66 years STANDARD_DEVIATION 12.17 • n=35 Participants
Sex: Female, Male Female	2 Participants n=39 Participants	3 Participants n=41 Participants	5 Participants n=35 Participants
Sex: Female, Male Male	5 Participants n=39 Participants	3 Participants n=41 Participants	8 Participants n=35 Participants

PRIMARY outcome

Timeframe: 6 weeks

measure of depression severity Theoretical Range 0-60 lower values represent better outcome

Outcome measures

Outcome measures
Measure	Buprenorphine n=5 Participants Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)	Placebo n=5 Participants Placebo: matched placebo
Montgomery Asberg Depression Rating Scale	33.8 units on a scale Standard Deviation 10.96	32.6 units on a scale Standard Deviation 2.07

PRIMARY outcome

Timeframe: 6 weeks

Measure of systolic and diastolic blood pressure. 140/90 or lower is considered normal and indicates a better outcome.

Outcome measures

Outcome measures
Measure	Buprenorphine n=5 Participants Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)	Placebo n=5 Participants Placebo: matched placebo
Blood Pressure Systolic Blood Pressure	138.4 mm Hg Standard Deviation 22.71	117.2 mm Hg Standard Deviation 28.1
Blood Pressure Diastolic Blood Pressure	91 mm Hg Standard Deviation 14.92	71 mm Hg Standard Deviation 15.92

PRIMARY outcome

Timeframe: 6 weeks

measure of side effects 46 items with scores of 0,1,2,3 possible. Theoretical range 0-138 Lower scores indicate fewer side effects

Outcome measures

Outcome measures
Measure	Buprenorphine n=5 Participants Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)	Placebo n=5 Participants Placebo: matched placebo
UKU Side Effect Rating Scale	29.2 units on a scale Standard Deviation 13.74	20.2 units on a scale Standard Deviation 5.36

PRIMARY outcome

Timeframe: 6 weeks

Heart Rate (Beats per minute) 60-100 beats per minute is considered normal lower heart rate represent healthier outcome

Outcome measures

Outcome measures
Measure	Buprenorphine n=5 Participants Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)	Placebo n=5 Participants Placebo: matched placebo
Heart Rate	87.25 Beats per minute Standard Deviation 12.84	72.6 Beats per minute Standard Deviation 19.73

PRIMARY outcome

Timeframe: 6 weeks

Participant weight

Outcome measures

Outcome measures
Measure	Buprenorphine n=5 Participants Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)	Placebo n=5 Participants Placebo: matched placebo
Weight	191.7 lbs Standard Deviation 30.02	203.7 lbs Standard Deviation 12.99

SECONDARY outcome

Timeframe: 6 weeks

measure of anxiety Lower numbers indicate better outcome Theoretical Range 0-2.4

Outcome measures

Outcome measures
Measure	Buprenorphine n=5 Participants Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)	Placebo n=5 Participants Placebo: matched placebo
Brief Symptom Inventory -- Anxiety Subscale	1.43 units on a scale Standard Deviation 1.1	0.97 units on a scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: 6 weeks

Population: reduced sample size verified. This was secondary to administrative error.

Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect. Negative Affect Score: Scores can range from 10 - 50, with lower scores representing lower levels of negative affect.

Outcome measures

Outcome measures
Measure	Buprenorphine n=4 Participants Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)	Placebo n=4 Participants Placebo: matched placebo
Positive and Negative Affect Scale PANAS positive affect subscale	13.75 units on a scale Standard Deviation 0.96	16.25 units on a scale Standard Deviation 2.99
Positive and Negative Affect Scale PANAS negative affect subscale	22 units on a scale Standard Deviation 11.4	20.5 units on a scale Standard Deviation 1.73

Adverse Events

Buprenorphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jordan F. Karp, MD

University of Pittsburgh

Phone: 412-246-6048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place