Trial Outcomes & Findings for Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine (NCT NCT02176291)

Last Updated: 2018-08-29

Results Overview

Measure of depression severity, range of 0-60 We calculated the mean change in depression severity for both groups using baseline MADRS and week 8 MADRS scores. Greater mean change represents better outcome.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

baseline and 8 weeks

Results posted on

2018-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	Buprenorphine Buprenorphine Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 2.0 mg/day)	Placebo Placebo Placebo: matched placebo
Overall Study STARTED	20	11
Overall Study COMPLETED	15	11
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Buprenorphine Buprenorphine Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 2.0 mg/day)	Placebo Placebo Placebo: matched placebo
Overall Study Death	1	0
Overall Study non compliance with protocol	2	0
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Buprenorphine n=20 Participants Buprenorphine Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 2.0 mg/day)	Placebo n=11 Participants Placebo Placebo: matched placebo	Total n=31 Participants Total of all reporting groups
Age, Continuous	64.7 years STANDARD_DEVIATION 9.7 • n=39 Participants	65.6 years STANDARD_DEVIATION 7.5 • n=41 Participants	65.0 years STANDARD_DEVIATION 8.9 • n=35 Participants
Sex: Female, Male Female	8 Participants n=39 Participants	3 Participants n=41 Participants	11 Participants n=35 Participants
Sex: Female, Male Male	12 Participants n=39 Participants	8 Participants n=41 Participants	20 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	4 Participants n=39 Participants	0 Participants n=41 Participants	4 Participants n=35 Participants
Race (NIH/OMB) White	16 Participants n=39 Participants	11 Participants n=41 Participants	27 Participants n=35 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Region of Enrollment United States	20 Participants n=39 Participants	11 Participants n=41 Participants	31 Participants n=35 Participants

PRIMARY outcome

Timeframe: baseline and 8 weeks

Outcome measures

Outcome measures
Measure	Buprenorphine n=15 Participants Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.2 mg/day)	Placebo n=11 Participants Placebo: matched placebo
Montgomery-Asberg Depression Rating Scale (MADRS) Change in MADRS	3.47 units on a scale Standard Deviation 8.94	4.09 units on a scale Standard Deviation 8.06
Montgomery-Asberg Depression Rating Scale (MADRS) Final MADRS score	16.93 units on a scale Standard Deviation 8.68	14.64 units on a scale Standard Deviation 9.41

SECONDARY outcome

Timeframe: Baseline and 8 weeks

Measure of Anxiety Theoretical Range 0-2.4 with lower numbers indicating a better outcome. We calculated the mean change in anxiety for both groups using Phase 1 week 12 time point (baseline) and Phase 2 week 8 time point (final time point).

Outcome measures

Outcome measures
Measure	Buprenorphine n=18 Participants Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.2 mg/day)	Placebo n=11 Participants Placebo: matched placebo
Brief Symptom Inventory--Anxiety Subscale (BSI) Change in BSI	0.07 units on a scale Standard Deviation 1.39	0.06 units on a scale Standard Deviation 0.80
Brief Symptom Inventory--Anxiety Subscale (BSI) Final BSI Score	0.74 units on a scale Standard Deviation 0.94	0.64 units on a scale Standard Deviation 0.48

Adverse Events

Buprenorphine

Serious events: 2 serious events

Other events: 12 other events

Deaths: 1 deaths

Placebo

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Buprenorphine n=20 participants at risk Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.2 mg/day)	Placebo n=11 participants at risk Placebo: matched placebo
Cardiac disorders death	5.0% 1/20 • Adverse events were collected over a period of 1 year and six months.	0.00% 0/11 • Adverse events were collected over a period of 1 year and six months.
Gastrointestinal disorders severe abdominal pain	0.00% 0/20 • Adverse events were collected over a period of 1 year and six months.	9.1% 1/11 • Adverse events were collected over a period of 1 year and six months.
General disorders nausea and hypertension	5.0% 1/20 • Adverse events were collected over a period of 1 year and six months.	0.00% 0/11 • Adverse events were collected over a period of 1 year and six months.
Respiratory, thoracic and mediastinal disorders pneumonia	0.00% 0/20 • Adverse events were collected over a period of 1 year and six months.	9.1% 1/11 • Adverse events were collected over a period of 1 year and six months.

Other adverse events

Additional Information

Dr. Jordan F. Karp

University of Pittsburgh

Phone: 412-246-6048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Buprenorphine n=20 participants at risk Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.2 mg/day)	Placebo n=11 participants at risk Placebo: matched placebo
General disorders Lightheadedness	21.1% 4/19 • Adverse events were collected over a period of 1 year and six months.	9.1% 1/11 • Adverse events were collected over a period of 1 year and six months.
General disorders Insomnia	15.0% 3/20 • Adverse events were collected over a period of 1 year and six months.	18.2% 2/11 • Adverse events were collected over a period of 1 year and six months.
General disorders Drowsiness	20.0% 4/20 • Adverse events were collected over a period of 1 year and six months.	0.00% 0/11 • Adverse events were collected over a period of 1 year and six months.
Gastrointestinal disorders Constipation	25.0% 5/20 • Adverse events were collected over a period of 1 year and six months.	18.2% 2/11 • Adverse events were collected over a period of 1 year and six months.
General disorders Dry Mouth	20.0% 4/20 • Adverse events were collected over a period of 1 year and six months.	0.00% 0/11 • Adverse events were collected over a period of 1 year and six months.
Gastrointestinal disorders Nausea	5.0% 1/20 • Adverse events were collected over a period of 1 year and six months.	9.1% 1/11 • Adverse events were collected over a period of 1 year and six months.
Cardiac disorders Increased Blood Pressure	10.0% 2/20 • Adverse events were collected over a period of 1 year and six months.	18.2% 2/11 • Adverse events were collected over a period of 1 year and six months.
General disorders Increased pulse	5.0% 1/20 • Adverse events were collected over a period of 1 year and six months.	9.1% 1/11 • Adverse events were collected over a period of 1 year and six months.
Renal and urinary disorders urinary frequency	10.0% 2/20 • Adverse events were collected over a period of 1 year and six months.	0.00% 0/11 • Adverse events were collected over a period of 1 year and six months.
General disorders Falls	5.0% 1/20 • Adverse events were collected over a period of 1 year and six months.	9.1% 1/11 • Adverse events were collected over a period of 1 year and six months.
General disorders Increased Sleep	0.00% 0/20 • Adverse events were collected over a period of 1 year and six months.	9.1% 1/11 • Adverse events were collected over a period of 1 year and six months.
General disorders Sweating	0.00% 0/20 • Adverse events were collected over a period of 1 year and six months.	9.1% 1/11 • Adverse events were collected over a period of 1 year and six months.
Psychiatric disorders Anxiety	0.00% 0/20 • Adverse events were collected over a period of 1 year and six months.	9.1% 1/11 • Adverse events were collected over a period of 1 year and six months.
General disorders Blurred vision	0.00% 0/20 • Adverse events were collected over a period of 1 year and six months.	9.1% 1/11 • Adverse events were collected over a period of 1 year and six months.
General disorders Decreased Libido	5.0% 1/20 • Adverse events were collected over a period of 1 year and six months.	0.00% 0/11 • Adverse events were collected over a period of 1 year and six months.
Nervous system disorders Myoclonus	5.0% 1/20 • Adverse events were collected over a period of 1 year and six months.	0.00% 0/11 • Adverse events were collected over a period of 1 year and six months.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/20 • Adverse events were collected over a period of 1 year and six months.	9.1% 1/11 • Adverse events were collected over a period of 1 year and six months.
Nervous system disorders Tremor	5.0% 1/20 • Adverse events were collected over a period of 1 year and six months.	0.00% 0/11 • Adverse events were collected over a period of 1 year and six months.
General disorders Headache	5.0% 1/20 • Adverse events were collected over a period of 1 year and six months.	0.00% 0/11 • Adverse events were collected over a period of 1 year and six months.
General disorders Coughing	0.00% 0/20 • Adverse events were collected over a period of 1 year and six months.	18.2% 2/11 • Adverse events were collected over a period of 1 year and six months.
Gastrointestinal disorders Diarrhea	0.00% 0/20 • Adverse events were collected over a period of 1 year and six months.	9.1% 1/11 • Adverse events were collected over a period of 1 year and six months.
General disorders Yawning	5.0% 1/20 • Adverse events were collected over a period of 1 year and six months.	0.00% 0/11 • Adverse events were collected over a period of 1 year and six months.
General disorders Weight gain	0.00% 0/20 • Adverse events were collected over a period of 1 year and six months.	9.1% 1/11 • Adverse events were collected over a period of 1 year and six months.
General disorders Myalgia	5.0% 1/20 • Adverse events were collected over a period of 1 year and six months.	0.00% 0/11 • Adverse events were collected over a period of 1 year and six months.
Endocrine disorders Increased plasma glucose level	5.0% 1/20 • Adverse events were collected over a period of 1 year and six months.	0.00% 0/11 • Adverse events were collected over a period of 1 year and six months.