Trial Outcomes & Findings for Buprenorphine for Late-Life Treatment Resistant Depression (NCT NCT01071538)

NCT ID: NCT01071538

Last Updated: 2018-03-09

Results Overview

measure of depression severity theoretical scale range 0-60 Lower values represent better outcome

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2018-03-09

Participant Flow

Participant milestones

Measure	Buprenorphine Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12. Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Buprenorphine for Late-Life Treatment Resistant Depression

Baseline characteristics by cohort

Measure	Buprenorphine n=15 Participants Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12. Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.
Age, Continuous	60.7 years STANDARD_DEVIATION 5.6 • n=93 Participants
Sex: Female, Male Female	8 Participants n=93 Participants
Sex: Female, Male Male	7 Participants n=93 Participants

PRIMARY outcome

Timeframe: 8 weeks

measure of depression severity theoretical scale range 0-60 Lower values represent better outcome

Outcome measures

Measure

Buprenorphine n=15 Participants Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12. Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

Montgomery Asberg Depression Rating Scale

9.5 units on a scale Standard Deviation 9.5

PRIMARY outcome

Timeframe: 8 weeks

Blood Pressure- systolic and diastolic 140/90 or lower is considered normal and indicates a better outcome.

Outcome measures

Measure	Buprenorphine n=13 Participants Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12. Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.
Blood Pressure systolic blood pressure	122.5 mm Hg Standard Deviation 23.0
Blood Pressure diastolic blood pressure	70.5 mm Hg Standard Deviation 12.1

PRIMARY outcome

Timeframe: 8 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

Measure

Buprenorphine n=13 Participants Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12. Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

UKU Side Effect Rating Scale

6.2 units on a scale Standard Deviation 3.5

PRIMARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure

Buprenorphine n=13 Participants Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12. Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

Heart Rate

72.7 beats per minute Standard Deviation 9.9

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure

Buprenorphine n=13 Participants Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12. Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

Brief Symptom Inventory -- Anxiety Subscale

0.6 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 8 weeks

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

Measure	Buprenorphine n=13 Participants Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12. Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.
Positive and Negative Affect Scale Positive affect subscale	29.4 units on a scale Standard Deviation 12.0
Positive and Negative Affect Scale Negative affect subscale	15.5 units on a scale Standard Deviation 6.7

SECONDARY outcome

Timeframe: 8 weeks

measure of average physical pain score range 0-20 Higher scores indicate worse outcome

Outcome measures

Measure

Buprenorphine n=13 Participants Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12. Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

Pain Numeric Rating Scale (20 Item)

4.6 units on a scale Standard Deviation 5.2

Adverse Events

Buprenorphine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Buprenorphine n=15 participants at risk Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12. Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

Gastrointestinal disorders constipation

6.7% 1/15 • Number of events 1

Additional Information

Jordan F. Karp, MD

University of Pittsburgh

Phone: 412-246-6048

Email: karpjf@upmc.edu

Results disclosure agreements

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