Status:
COMPLETED
Buprenorphine for Treatment Resistant Depression
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Alliance for Research on Schizophrenia and Depression
Conditions:
Depression
Depressive Disorder
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the safety and efficacy of buprenorphine with placebo for adults with treatment resistant depression (TRD).
Detailed Description
Rates of treatment resistant depression (TRD) in randomized controlled trials range from 50-80% using SSRIs and SNRIs. Innovative treatments are sorely needed. Modulation of the opiate system may be a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01407575
Start Date
September 1 2011
End Date
August 1 2013
Last Update
March 9 2018
Active Locations (1)
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1
Western Psychiatric Institute and Clinic, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213