NCT01071538

Brief Summary

The goals of this pilot study are to gather data about the safety and clinical effect of low-dose buprenorphine in older adults with treatment resistant depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2 depression

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

March 17, 2016

Completed
Last Updated

March 9, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

February 17, 2010

Results QC Date

January 7, 2016

Last Update Submit

February 9, 2018

Conditions

Depression

Keywords

Depressive Disorder, MajorLate-Life DepressionGeriatricsBuprenorphine

Outcome Measures

Primary Outcomes (4)

  • Montgomery Asberg Depression Rating Scale

    measure of depression severity theoretical scale range 0-60 Lower values represent better outcome

    8 weeks

  • Blood Pressure

    Blood Pressure- systolic and diastolic 140/90 or lower is considered normal and indicates a better outcome.

    8 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

    8 weeks

  • Heart Rate

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

    8 weeks

Secondary Outcomes (3)

  • Brief Symptom Inventory -- Anxiety Subscale

    8 weeks

  • Positive and Negative Affect Scale

    8 weeks

  • Pain Numeric Rating Scale (20 Item)

    8 weeks

Study Arms (1)

Buprenorphine

EXPERIMENTAL

Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.

Drug: Buprenorphine

Interventions

BuprenorphineDRUG

Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.

Buprenorphine

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>/= 50 years
  • 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.

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.
  • 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.
  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute and Clinica, University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

  • Mague SD, Pliakas AM, Todtenkopf MS, Tomasiewicz HC, Zhang Y, Stevens WC Jr, Jones RM, Portoghese PS, Carlezon WA Jr. Antidepressant-like effects of kappa-opioid receptor antagonists in the forced swim test in rats. J Pharmacol Exp Ther. 2003 Apr;305(1):323-30. doi: 10.1124/jpet.102.046433.

    PMID: 12649385BACKGROUND

  • Nyhuis PW, Gastpar M, Scherbaum N. Opiate treatment in depression refractory to antidepressants and electroconvulsive therapy. J Clin Psychopharmacol. 2008 Oct;28(5):593-5. doi: 10.1097/JCP.0b013e31818638a4. No abstract available.

    PMID: 18794671BACKGROUND

  • Bodkin JA, Zornberg GL, Lukas SE, Cole JO. Buprenorphine treatment of refractory depression. J Clin Psychopharmacol. 1995 Feb;15(1):49-57. doi: 10.1097/00004714-199502000-00008.

    PMID: 7714228BACKGROUND

  • Emrich HM, Vogt P, Herz A. Possible antidepressive effects of opioids: action of buprenorphine. Ann N Y Acad Sci. 1982;398:108-12. doi: 10.1111/j.1749-6632.1982.tb39483.x. No abstract available.

    PMID: 6760767BACKGROUND

  • Karp JF, Butters MA, Begley AE, Miller MD, Lenze EJ, Blumberger DM, Mulsant BH, Reynolds CF 3rd. Safety, tolerability, and clinical effect of low-dose buprenorphine for treatment-resistant depression in midlife and older adults. J Clin Psychiatry. 2014 Aug;75(8):e785-93. doi: 10.4088/JCP.13m08725.

    PMID: 25191915DERIVED

Related Links

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

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 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 17, 2010

First Posted

February 19, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

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)