A Phase 2 interventional study of Buprenorphine in Depression, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-03-09.
Sponsored by University of Pittsburgh · Phase 2, Interventional, and Treatment
The goals of this pilot study are to gather data about the safety and clinical effect of low-dose buprenorphine in older adults with treatment resistant depression.
We are recruiting 20 participants for this pilot study. Subjects are recruited from either:
Overview of intervention: To guide future placebo-controlled work, at this preliminary stage of research we will collect data about both buprenorphine (BUP) 1) augmentation pharmacotherapy, and 2) monotherapy. Subjects recruited from the community will have the buprenorphine prescribed as augmentation to any currently prescribed antidepressant medication.
BUP 0.2 mg will be used for the first week. The first dose will be administered at the clinic under the supervision of the PI. Because peak plasma levels occur 60 minutes after ingestion, subjects will be re-assessed after 1 hour for safety. Participants will be seen weekly for eight weeks to assess progress and monitor intervention-emergent side effects. Dosing increases will be guided by antidepressant response (e.g., continued MADRS scores > 10 will trigger an increase dose of BUP) and our protocolized use of the Frequency, Intensity, and Burden of Side Effect Rating (FIBSER) Scale score. For example, a score of 5 to 7 on the FIBSER will trigger additional assessment of side effects and require justification for increasing the dose, while a score of > 7 will signal no increase in dose, although specific side effects should be reviewed in detail before a final determination, including review if the UKU Side Effects Rating Scale.
We will increase the dose by 0.2 mg/week up to 1.6 mg/day based on MADRS and FIBSER scores. Every time the dose is increased, the first ingestion of the higher dose will be monitored in the clinic as described above.
Subjects will participate in the project at the Late-Life Depression Clinic on the 7th Floor of Bellefield Tower. Subjects will complete paper and pencil and clinician-administered psychiatric assessments before receiving the first dose of buprenorphine and at all subsequent visits. After the first ingestion and all subsequent first ingestions of higher doses of BUP, subjects will remain in the clinic for 60 minutes after ingestion and be re-assessed for the emergence of side effects and have vital signs re-checked. The duration of the first visit will be approximately 2.5 hours. If subsequent visits require observed ingestion of buprenorphine, they will last about 1.75 hours. If subsequent visits do not require observed ingestion of buprenorphine, these visits will last 30-45 minutes.
Prior to the first ingestion, the first ingestion of subsequent higher doses, and at study end, subjects will complete a 15 minute battery of computerized neuropsychological tests assessing reaction time and attention. These tests will be repeated 60 minutes after the ingestion. Prior to the first ingestion and after discontinuation of the buprenorphine, memory will be assessed with the Hopkins Verbal Learning Test (HVLT). The HVLT takes about 10 minutes to complete.
The discontinuation phase will occur during weeks 9-12. To minimize the risk of withdrawal symptoms, we will discontinue the buprenorphine slowly by reducing the dose to 0.4 mg/day for 7 days, then 0.2 mg/day every other day for 7 days, and then stop the buprenorphine. We will see subjects weekly over these four weeks.
The final visit will occur at week 16. This will be a telephone check in of mood and functioning. This call will take about 15-20 minutes.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 15 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: 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
measure of depression severity theoretical scale range 0-60 Lower values represent better outcome
Time frame: 8 weeks
Blood Pressure
Blood Pressure- systolic and diastolic 140/90 or lower is considered normal and indicates a better outcome.
Time frame: 8 weeks
UKU Side Effect Rating Scale
measure of side effects 46 items with scores of 0,1,2,3 possible. Theoretical range 0-138 Lower scores indicate fewer side effects
Time frame: 8 weeks
Heart Rate
Heart Rate (Beats per minute) 60-100 beats per minute is considered normal lower heart rate represent healthier outcome
Time frame: 8 weeks
Brief Symptom Inventory -- Anxiety Subscale
measure of anxiety Lower numbers indicate better outcome Theoretical Range 0-2.4
Time frame: 8 weeks
Positive and Negative Affect Scale
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.
Time frame: 8 weeks
Pain Numeric Rating Scale (20 Item)
measure of average physical pain score range 0-20 Higher scores indicate worse outcome
Time frame: 8 weeks
| Milestone | Buprenorphine |
|---|---|
| Started | 15 |
| Completed | 13 |
| Not completed | 2 |
measure of depression severity theoretical scale range 0-60 Lower values represent better outcome
| units on a scale | Buprenorphine |
|---|---|
| Montgomery Asberg Depression Rating Scale | 9.5 ± 9.5 |
Blood Pressure- systolic and diastolic 140/90 or lower is considered normal and indicates a better outcome.
| mm Hg | Buprenorphine |
|---|---|
| systolic blood pressure | 122.5 ± 23.0 |
| diastolic blood pressure | 70.5 ± 12.1 |
measure of side effects 46 items with scores of 0,1,2,3 possible. Theoretical range 0-138 Lower scores indicate fewer side effects
| units on a scale | Buprenorphine |
|---|---|
| UKU Side Effect Rating Scale | 6.2 ± 3.5 |
measure of anxiety Lower numbers indicate better outcome Theoretical Range 0-2.4
| units on a scale | Buprenorphine |
|---|---|
| Brief Symptom Inventory -- Anxiety Subscale | 0.6 ± 0.8 |
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.
| units on a scale | Buprenorphine |
|---|---|
| Positive affect subscale | 29.4 ± 12.0 |
| Negative affect subscale | 15.5 ± 6.7 |
measure of average physical pain score range 0-20 Higher scores indicate worse outcome
| units on a scale | Buprenorphine |
|---|---|
| Pain Numeric Rating Scale (20 Item) | 4.6 ± 5.2 |
Heart Rate (Beats per minute) 60-100 beats per minute is considered normal lower heart rate represent healthier outcome
| beats per minute | Buprenorphine |
|---|---|
| Heart Rate | 72.7 ± 9.9 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Buprenorphine | — | 0/15 (0%) | 1/15 (6.7%) |
| Event | Buprenorphine |
|---|---|
| constipationGastrointestinal disorders | 1/15 |
| Age, Continuous(years) | Buprenorphine |
|---|---|
| Mean | 60.7 ± 5.6 |
| Sex: Female, Male(Participants) | Buprenorphine |
|---|---|
| Female | 8 |
| Male | 7 |
Plan to share: No
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Pittsburgh