Buprenorphine for Treatment Resistant Depression

NCT01407575 | Completed Phase 3 Results

• 1 other identifier: BUP-TRD
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression; Depressive Disorder; Depressive Disorder, Major

Keywords

Buprenorphine; Receptors, opioid; Receptors, opioid, kappa

Outcome Measures

Primary Outcomes (5)

• Montgomery Asberg Depression Rating Scale

  measure of depression severity Theoretical Range 0-60 lower values represent better outcome

  6 weeks

• Blood Pressure

  Measure of systolic and diastolic blood pressure. 140/90 or lower is considered normal and indicates a better outcome.

  6 weeks

• UKU Side Effect Rating Scale

  measure of side effects 46 items with scores of 0,1,2,3 possible. Theoretical range 0-138 Lower scores indicate fewer side effects

  6 weeks

• Heart Rate

  Heart Rate (Beats per minute) 60-100 beats per minute is considered normal lower heart rate represent healthier outcome

  6 weeks

• Weight

  Participant weight

  6 weeks

Secondary Outcomes (2)

• Brief Symptom Inventory -- Anxiety Subscale

  6 weeks

• Positive and Negative Affect Scale

  6 weeks

Study Arms (2)

Buprenorphine

EXPERIMENTAL

0.2 to 1.6mg of buprenorphine sublingual over the course of 8 weeks

Drug: Buprenorphine

Placebo

PLACEBO COMPARATOR

matching placebo- sublingual- over the course of 8 weeks

Drug: Placebo

Interventions

Buprenorphine DRUG

low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)

Also known as: suboxone, buprenex, temgesic, subutex

Buprenorphine

Placebo DRUG

matched placebo

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Western Psychiatric Institute and Clinic, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder; Depressive Disorder, Major

Interventions

Buprenorphine; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Jordan F. Karp, MD
• Organization: University of Pittsburgh

karpjf@upmc.edu

412-246-6048

Study Officials

• Jordan F Karp, M.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: August 2, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 9, 2018
• Results First Posted: March 17, 2016

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)