Phase 2
Completed N=31
Incomplete Response in Late-Life Depression: Getting to Remission With Buprenorphine
Source: ClinicalTrials.gov NCT02176291 ↗Enrolled (actual)
31
Serious AEs
12.9%
Results posted
Jul 2018
Primary outcomePrimary: Montgomery-Asberg Depression Rating Scale (MADRS) — 3.47; 4.09; 16.93; 14.64 units on a scale
Summary
The purposes of this project are to examine the feasibility, safety, tolerability and clinical effect of low-dose buprenorphine as a novel treatment for late-life treatment-resistant depression and to develop preliminary data about mechanism of action.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery-Asberg Depression Rating Scale (MADRS) |
3.47; 4.09; 16.93; 14.64 | — |
| SECONDARY Brief Symptom Inventory--Anxiety Subscale (BSI) |
0.07; 0.06; 0.74; 0.64 | — |
Eligibility Criteria
Inclusion Criteria
- Age >/= to 50 years.
- Major depressive disorder (MDD), single or recurrent, as diagnosed by the Structured Clinical Interview for the DSM IV (SCID-IV).
- Montgomery-Åsberg 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., Montgomery-Åsberg Depression Rating Scale ( MADRS) /= 7 on 0-10 numeric rating scale for pain.
- Concomitant use of strong or moderate CYP3A4 inhibitor (indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketonazole, nefazodone, saquinovir, telithromycin, aprepitant, erythromycin, fluconazole, grapefruit juice, verapamil, diltiazem)
- Refusal to stop all opioids (to avoid precipitating opioid withdrawal).
- Hepatic impairment- aspartate aminotransferase (AST) /alanine aminotransferase (ALT) > 1.5 times upper normal. If AST and ALT are within 1.5 times the upper limit, and subjects are asymptomatic, they will be considered medically stable to participate
- Estimated Glomerular Filtration Rate (GFR) < 20 ml/min.
- Inability/refusal to identify a person as an emergency contact.
- Pregnancy
- Contraindications to MRI
Data sourced from ClinicalTrials.gov (NCT02176291). 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. Informational only — not medical advice.