Trial Outcomes & Findings for Buprenorphine Used With Treatment Resistant Depression in Older Adults (NCT NCT02181231)
NCT ID: NCT02181231
Last Updated: 2019-06-04
Results Overview
Measure of depression severity, range of 0-60, with higher scores indicating more severe depression. We calculated the mean change in depression for both groups using baseline MADRS and week 8 MADRS scores.
COMPLETED
PHASE1/PHASE2
18 participants
Baseline and 8 weeks
2019-06-04
Participant Flow
Participant milestones
| Measure |
Buprenorphine
Drug: low dose buprenorphine (range .2mg/day-2.0mg/day)
|
Placebo
Drug: placebo Matched placebo
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
6
|
|
Overall Study
COMPLETED
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Buprenorphine Used With Treatment Resistant Depression in Older Adults
Baseline characteristics by cohort
| Measure |
Buprenorphine
n=12 Participants
Drug: buprenorphine Low-dose buprenorphine (range 0.2mg/day-2.0mg/day)
|
Placebo
n=6 Participants
Drug: matched placebo
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
60.8 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
64 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
6 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksMeasure of depression severity, range of 0-60, with higher scores indicating more severe depression. We calculated the mean change in depression for both groups using baseline MADRS and week 8 MADRS scores.
Outcome measures
| Measure |
Buprenorphine
n=10 Participants
Drug: low dose buprenorphine (range .2mg/day-2.0mg/day)
|
Placebo
n=6 Participants
Drug: placebo Matched placebo
|
|---|---|---|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Change in MADRS
|
-1 units on a scale
Standard Deviation 6.8
|
-5.3 units on a scale
Standard Deviation 8.8
|
|
Montgomery-Asberg Depression Rating Scale (MADRS)
Final MADRS Score
|
21.3 units on a scale
Standard Deviation 6.7
|
15.3 units on a scale
Standard Deviation 11.5
|
PRIMARY outcome
Timeframe: Week 1 and week 8Three item side effect scale used to assess frequency and intensity of side effects (range 0-6 for each item). We calculated the total score of all three items (range 0-18) with lower numbers indicating less frequency. We calculated the mean score at baseline and week 8 (final timepoint).
Outcome measures
| Measure |
Buprenorphine
n=10 Participants
Drug: low dose buprenorphine (range .2mg/day-2.0mg/day)
|
Placebo
n=6 Participants
Drug: placebo Matched placebo
|
|---|---|---|
|
Frequency, Intensity, and Burden of Side Effects Rating (FIBSER)
Mean baseline score
|
5.6 score on a scale
Standard Deviation 3.9
|
1.3 score on a scale
Standard Deviation 3.2
|
|
Frequency, Intensity, and Burden of Side Effects Rating (FIBSER)
Final FIBSER Score
|
3.8 score on a scale
Standard Deviation 4.0
|
.5 score on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Baseline and 8 weeksMeasure of side effects, consisting of 21 items, ranging from 0-3 (0 indicates no side effect, 3 indicates severe side effect). We calculated the total final score for the 21 items (total range is 0-63). A higher total number represents a greater severity in reported side effects. We calculated the mean change in side effects for both groups using baseline and 8 week data.
Outcome measures
| Measure |
Buprenorphine
n=10 Participants
Drug: low dose buprenorphine (range .2mg/day-2.0mg/day)
|
Placebo
n=6 Participants
Drug: placebo Matched placebo
|
|---|---|---|
|
Antidepressant Side Effect Checklist (ASEC)
Change in ASEC
|
1 units on a scale
Standard Deviation 7.0
|
1.8 units on a scale
Standard Deviation 5.5
|
|
Antidepressant Side Effect Checklist (ASEC)
Final ASEC score
|
11.4 units on a scale
Standard Deviation 7.6
|
8.5 units on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksA 19 item scale used to measure the presence or absence of suicidal ideations and the degree of severity of suicidal ideas. For this study, we computed the total score for all 19 items (total range 0-90). Higher scores represent a worse outcome. We also calculated the mean change in suicidal ideation for both groups using baseline and week 8 (final timepoint).
Outcome measures
| Measure |
Buprenorphine
n=10 Participants
Drug: low dose buprenorphine (range .2mg/day-2.0mg/day)
|
Placebo
n=6 Participants
Drug: placebo Matched placebo
|
|---|---|---|
|
Suicide Ideation Scale (SIS)
Change in SIS
|
-.2 units on a scale
Standard Deviation 4.7
|
-1 units on a scale
Standard Deviation 3.0
|
|
Suicide Ideation Scale (SIS)
Final SIS score
|
1.1 units on a scale
Standard Deviation 3.5
|
4.7 units on a scale
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksMeasure of anxiety. Six anxiety symptoms are rated based on how distressed the subject is for each symptom. The range for each symptom is 0-4, with 4 representing extreme distress. We computed the mean of the final BSI score (range 0-24), with a lower number indicating a better outcome. We also calculated the mean change in anxiety for both groups using baseline and Phase 2 week 8 (final time point) data.
Outcome measures
| Measure |
Buprenorphine
n=10 Participants
Drug: low dose buprenorphine (range .2mg/day-2.0mg/day)
|
Placebo
n=6 Participants
Drug: placebo Matched placebo
|
|---|---|---|
|
Brief Symptom Inventory-Anxiety Subscale (BSI)
Change in BSI
|
.7 units on a scale
Standard Deviation 2.8
|
0 units on a scale
Standard Deviation 1.3
|
|
Brief Symptom Inventory-Anxiety Subscale (BSI)
Final BSI score
|
3 units on a scale
Standard Deviation 3.7
|
2.7 units on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksMeasure used to assess pain, ranging from 0-10, with 10 being the worst possible pain. We calculated the mean change in pain for both groups using baseline and week 8 (last time point).
Outcome measures
| Measure |
Buprenorphine
n=10 Participants
Drug: low dose buprenorphine (range .2mg/day-2.0mg/day)
|
Placebo
n=6 Participants
Drug: placebo Matched placebo
|
|---|---|---|
|
Numeric Scale of Pain (NRS-P)
Change in NRS-P
|
-1.1 units on a scale
Standard Deviation 2.4
|
-1.3 units on a scale
Standard Deviation 2.0
|
|
Numeric Scale of Pain (NRS-P)
Final NRS-P score
|
2.9 units on a scale
Standard Deviation 2.0
|
2.8 units on a scale
Standard Deviation 3.2
|
Adverse Events
Buprenorphine
Placebo
Serious adverse events
| Measure |
Buprenorphine
n=12 participants at risk
Drug: low dose buprenorphine (range .2mg/day-2.0mg/day)
|
Placebo
n=6 participants at risk
Drug: placebo Matched placebo
|
|---|---|---|
|
Cardiac disorders
Hospitalization
|
0.00%
0/12 • 8 weeks
|
16.7%
1/6 • Number of events 1 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for Pneumonia
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
Other adverse events
| Measure |
Buprenorphine
n=12 participants at risk
Drug: low dose buprenorphine (range .2mg/day-2.0mg/day)
|
Placebo
n=6 participants at risk
Drug: placebo Matched placebo
|
|---|---|---|
|
General disorders
Dry mouth
|
66.7%
8/12 • 8 weeks
|
33.3%
2/6 • 8 weeks
|
|
General disorders
Decreased appetite
|
25.0%
3/12 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
General disorders
Increased appetite
|
16.7%
2/12 • 8 weeks
|
16.7%
1/6 • 8 weeks
|
|
General disorders
Blurred vision
|
16.7%
2/12 • 8 weeks
|
16.7%
1/6 • 8 weeks
|
|
Gastrointestinal disorders
Constipation
|
58.3%
7/12 • 8 weeks
|
33.3%
2/6 • 8 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/12 • 8 weeks
|
33.3%
2/6 • 8 weeks
|
|
General disorders
Drowsiness
|
66.7%
8/12 • 8 weeks
|
16.7%
1/6 • 8 weeks
|
|
General disorders
Headaches
|
25.0%
3/12 • 8 weeks
|
33.3%
2/6 • 8 weeks
|
|
Cardiac disorders
Palpatations
|
25.0%
3/12 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
General disorders
Disorientation
|
16.7%
2/12 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
General disorders
Room spinning
|
25.0%
3/12 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
General disorders
Lightheadedness
|
66.7%
8/12 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • 8 weeks
|
16.7%
1/6 • 8 weeks
|
|
General disorders
Sweating
|
33.3%
4/12 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
General disorders
Increased body temperature
|
16.7%
2/12 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
General disorders
Ringing in ears
|
8.3%
1/12 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Nervous system disorders
Tremor
|
16.7%
2/12 • 8 weeks
|
16.7%
1/6 • 8 weeks
|
|
General disorders
Yawning
|
25.0%
3/12 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Renal and urinary disorders
Urinary problems
|
8.3%
1/12 • 8 weeks
|
16.7%
1/6 • 8 weeks
|
|
General disorders
Swollen hands and ankles
|
16.7%
2/12 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
General disorders
Hives
|
8.3%
1/12 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
General disorders
Itching
|
8.3%
1/12 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
Gastrointestinal disorders
Increased intestinal gas
|
8.3%
1/12 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
General disorders
Falls
|
8.3%
1/12 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
|
General disorders
Weight gain
|
8.3%
1/12 • 8 weeks
|
0.00%
0/6 • 8 weeks
|
Additional Information
Dr. Eric Lenze
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place