Buprenorphine for Late-Life Treatment Resistant Depression

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborators: National Center for Research Resources (NCRR); National Institutes of Health (NIH); Reckitt Benckiser LLC
• Treatments: Buprenorphine

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.