Phase 3 N=13 Randomized Triple-blind Treatment

Buprenorphine for Treatment Resistant Depression

Depression · Depressive Disorder · Depressive Disorder, Major

Bottom Line

View on ClinicalTrials.gov: NCT01407575 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcome: Primary: Montgomery Asberg Depression Rating Scale — 33.8; 32.6 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Buprenorphine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Pittsburgh
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Montgomery Asberg Depression Rating Scale	33.8; 32.6	—
PRIMARY Blood Pressure	138.4; 117.2; 91; 71	—
PRIMARY UKU Side Effect Rating Scale	29.2; 20.2	—
PRIMARY Heart Rate	87.25; 72.6	—
PRIMARY Weight	191.7; 203.7	—
SECONDARY Brief Symptom Inventory -- Anxiety Subscale	1.43; 0.97	—
SECONDARY Positive and Negative Affect Scale	13.75; 16.25; 22; 20.5	—

Summary

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

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01407575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.