Buprenorphine for Treatment Resistant Depression

Completed · Phase 3 · Has a placebo group

Conditions studied: Depression, Depressive Disorder, Depressive Disorder, Major

In brief

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

Key facts

Study ID

NCT01407575

Run by

University of Pittsburgh

People needed

13

Starts

2011-09-01

Expected to finish

2013-08-01

Last updated by the study team

2018-03-09

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

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 (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.

Where it is running

• Western Psychiatric Institute and Clinic, University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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