Phase 2
N=18
Buprenorphine Used With Treatment Resistant Depression in Older Adults
Major Depressive Disorder · Depression
Bottom Line
View on ClinicalTrials.gov: NCT02181231 ↗Enrolled (actual)
18
Serious AEs
11.1%
Results posted
Jun 2019
Primary outcome: Primary: Montgomery-Asberg Depression Rating Scale (MADRS) — -1; -5.3; 21.3; 15.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- venlafaxine XR (Drug); buprenorphine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery-Asberg Depression Rating Scale (MADRS) |
-1; -5.3; 21.3; 15.3 | — |
| PRIMARY Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) |
5.6; 1.3; 3.8; .5 | — |
| PRIMARY Antidepressant Side Effect Checklist (ASEC) |
1; 1.8; 11.4; 8.5 | — |
| SECONDARY Suicide Ideation Scale (SIS) |
-.2; -1; 1.1; 4.7 | — |
| SECONDARY Brief Symptom Inventory-Anxiety Subscale (BSI) |
.7; 0; 3; 2.7 | — |
| SECONDARY Numeric Scale of Pain (NRS-P) |
-1.1; -1.3; 2.9; 2.8 | — |
Summary
The investigators are conducting a research study to learn about the safety and benefit of using a medication called buprenorphine for patients with difficult to treat depression. This research study is testing whether combining two medications will be effective in treating depression when initial treatment with just one antidepressant does not relieve the depressive symptoms; this is what is called "difficult to treat depression" or "treatment resistant depression". The two medications the investigators are using are: an anti-depressant medication called venlafaxine extended release (venlafaxine XR), which is the generic form of Effexor, and buprenorphine. Buprenorphine is a medication that is FDA approved for the treatment of opioid dependence. The investigators are testing whether adding buprenorphine to venlafaxine XR enhances treatment response.
Eligibility Criteria
Inclusion Criteria for Main Study:
- Age > or = to 50 years.
- Major depressive disorder (MDD), single or recurrent, as diagnosed by the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID-IV).
- Montgomery Asberg Depression Rating Scale (MADRS) >/= to 15.
- Has or agrees to establish a clinical relationship with primary care physician (PCP).
- Availability of an informant (e.g., emergency contact).
Exclusion Criteria
- Inability to provide informed consent.
- Depressive symptoms not severe enough (i.e., MADRS 7 on 0-10 numeric rating scale for pain.
- Concomitant use of strong or moderate CYP3A4 inhibitor (indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, telithromycin, aprepitant, erythromycin, fluconazole, grapefruit juice, verapamil, diltiazem).
- Refusal to stop all opioids (to avoid precipitating opioid withdrawal).
- Hepatic impairment
- Estimated Glomerular Filtration Rate (GFR) < 20 ml/min.
- Inability/refusal to identify a person as an emergency contact.
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT02181231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.