Phase 2
Completed N=15
Buprenorphine for Late-Life Treatment Resistant Depression
Source: ClinicalTrials.gov NCT01071538 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Montgomery Asberg Depression Rating Scale — 9.5 units on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery Asberg Depression Rating Scale |
9.5 | — |
| PRIMARY Blood Pressure |
122.5; 70.5 | — |
| PRIMARY UKU Side Effect Rating Scale |
6.2 | — |
| PRIMARY Heart Rate |
72.7 | — |
| SECONDARY Brief Symptom Inventory -- Anxiety Subscale |
0.6 | — |
| SECONDARY Positive and Negative Affect Scale |
29.4; 15.5 | — |
| SECONDARY Pain Numeric Rating Scale (20 Item) |
4.6 | — |
Eligibility Criteria
Inclusion Criteria
- Age >/= 50 years
- Major depressive disorder
- Non-responder to at least 2 FDA-approved antidepressants prescribed at a therapeutic dose, each for at least 6 weeks, or is a depression non-responder from an ongoing study of late-life depression at our research clinic.
Exclusion Criteria
- Concomitant use of strong or moderate CYP3A4 inhibitor.
- Refusal to stop all opioids.
- Refusal to discontinue all alcohol.
- Refusal to discontinue benzodiazepines other than the equivalent of lorazepam 2 mg/day prescribed at a stable dose for at least the past 2 weeks.
- Hepatic impairment (AST/ALT > 1.5 times upper normal.
- Lung disease requiring supplemental oxygen.
- Estimated creatinine clearance <30 mL/min.
- Inability to provide informed consent.
- Depressive symptoms not severe enough (i.e., MADRS < 10) at the baseline assessment.
- Dementia.
- Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.
- Abuse of or dependence on alcohol or other substances within the past 3 months.
- Meets criteria for history of abuse or dependence upon opioids.
- High risk for suicide.
- Contraindication to buprenorphine.
- Inability to communicate in English.
- Non-correctable clinically significant sensory impairment.
- Unstable medical illness.
- Subjects taking psychotropic medications that cannot be safely tapered and discontinued prior to study initiation.
Data sourced from ClinicalTrials.gov (NCT01071538). 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.