Buprenorphine for Late-Life Treatment Resistant Depression
Completed · Phase 2
Conditions studied: Depression
In brief
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.
Key facts
- Study ID
- NCT01071538
- Run by
- University of Pittsburgh
- People needed
- 15
- Starts
- 2010-05-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2018-03-09
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Western Psychiatric Institute and Clinica, University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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