Buprenorphine for Treatment Resistant Depression

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the safety and efficacy of buprenorphine with placebo for adults with treatment resistant depression (TRD).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: National Alliance for Research on Schizophrenia and Depression
• Treatments: Buprenorphine

Criteria

Inclusion Criteria:

• Age 21 and older

• 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.

• For women of child-bearing age, must have negative pregnancy test and agree not to get pregnant while participating.

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 (CPAP for sleep apnea is acceptable).

• 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, as defined by MMSE < 24 and clinical evidence of 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.