Evidence map›Paper›PMID 25191915›Full record

Trial reportThe Journal of clinical psychiatry2014

Safety, tolerability, and clinical effect of low-dose buprenorphine for treatment-resistant depression in midlife and older adults.

Jordan F Karp, Meryl A Butters, Amy E Begley, Mark D Miller, Eric J Lenze, Daniel M Blumberger, Benoit H Mulsant, Charles F Reynolds

2 registry-linked trialsOpen access · greenAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of clinical psychiatry, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 95 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 4 pooled it
15.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01071538 phase2completednot on this map

Buprenorphine for Late-Life Treatment Resistant Depression

TypeinterventionalSponsorUniversity of PittsburghRan2010 to 2012Enrolled15ConditionsDepressionArmsBuprenorphine
NCT02659787 nacompletednot on this mapstarted 2016, after this paper: background citation

Effects of Buprenorphine on Mood in Adults With a Range of Depressive Symptomatology

TypeinterventionalSponsorUniversity of ChicagoRan2016 to 2017Enrolled38ConditionsDepressionArms0.2mg Buprenorphine, Placebo
3 · Its place in the literature

Who cites it

95 citing papers in PubMed, 4 syntheses or guidelines pooled it, 190 citations in OpenAlex.

  1. Pooled it
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  7. Results from a long-term open-label extension study of adjunctive buprenorphine/samidorphan combination in patients with major depressive disorder.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2019
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  12. Evaluation of opioid modulation in major depressive disorder.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2015
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35 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Jordan F KarpWPIC, 3811 O'Hara St, Pittsburgh, PA 15213 karpjf@upmc.edu.
Meryl A Butters
Amy E Begley
Mark D Miller
Eric J Lenze
Daniel M Blumberger
Benoit H Mulsant
Charles F Reynolds
UPMC Health System · US

Funding

UNIVERSITY OF PITTSBURGH CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: BPCAUL1RR024153 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$73.9M
University of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8M
VARIABILITY, STABILITY & SMOOTHNESS OF WALKINGP30AG024827 · NIA · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI JENNIFER S BRACH · 2004 to 2026
$28.6M
University of Pittsburgh Clinical and Translational Science InstitutionKL2RR024154 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$22.2M
RESEARCH TRAINING COREP60MD000207 · NIMHD · UNIV OF MARYLAND, COLLEGE PARK · PI THOMAS, STEPHEN B. · 2002 to 2011
$10.8M
University of Pittsburgh Clinical and Translational Science InstitutionKL2TR000146 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$8.7M
RESEARCH METHODS COREP30MH090333 · NIMH · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REYNOLDS, CHARLES F · 2011 to 2015
$8.3M
1/3-Incomplete Response in Late-Life Depression: Getting to RemissionR01MH083660 · NIMH · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REYNOLDS, CHARLES F. · 2009 to 2013
$2.7M
Optimizing Care for Older Adults with Back Pain and DepressionR01AG033575 · NIA · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI KARP, JORDAN F · 2010 to 2014
$2.3M
Pathways Linking Late-Life Depression to MCI &DementiaR01MH072947 · NIMH · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BUTTERS, MERYL A · 2005 to 2009
$2.0M
NCATS NIH HHS KL2 TR000146NCATS NIH HHS UL1 TR000005NCRR NIH HHS KL2 RR024154NCRR NIH HHS UL1 RR024153NIA NIH HHS AG033575NIA NIH HHS P30 AG024827NIA NIH HHS R01 AG033575NIMHD NIH HHS P60 MD000207NIMH NIH HHS MH072947NIMH NIH HHS MH083660NIMH NIH HHS P30 MH090330NIMH NIH HHS P30 MH090333NIMH NIH HHS R01 MH072947NIMH NIH HHS R01 MH083660
6 · The paper itself

Abstract

objectiveTo describe the clinical effect and safety of low-dose buprenorphine, a κ-opioid receptor antagonist, for treatment-resistant depression (TRD) in midlife and older adults.

methodIn an 8-week open-label study, buprenorphine was prescribed for 15 adults aged 50 years or older with TRD, diagnosed with the Structured Clinical Interview for DSM-IV, between June 2010 and June 2011. The titrated dose of buprenorphine ranged from 0.2-1.6 mg/d. We assessed clinical change in depression, anxiety, sleep, positive and negative affect, and quality of life. The Montgomery-Asberg Depression Rating scale (MADRS) served as the main outcome measure. Tolerability was assessed by documenting side effects and change in vital signs, weight, and cognitive function. Clinical response durability was assessed 8 weeks after discontinuation of buprenorphine.

resultsThe mean dose of buprenorphine was 0.4 mg/d (mean maximum dose = 0.7 mg/d). The mean depression score (MADRS) at baseline was 27.0 (SD = 7.3) and at week 8 was 9.5 (SD = 9.5). A sharp decline in depression severity occurred during the first 3 weeks of exposure (mean change = -15.0 [SD = 7.9]). Depression-specific items measuring pessimism and sadness indicated improvement during exposure, supporting a true antidepressant effect. Treatment-emergent side effects (in particular, nausea and constipation) were not sustained, vital signs and weight remained stable, and executive function and learning improved from pretreatment to posttreatment.

conclusionLow-dose buprenorphine may be a novel-mechanism medication that provides a rapid and sustained improvement for older adults with TRD. Placebo-controlled trials of longer duration are required to assess efficacy, safety, and physiologic and psychological effects of extended exposure to this medication.

trial registrationClinicalTrials.gov identifier: NCT01071538.

Indexed as

AgedAge of OnsetBuprenorphineCognitionDepressive Disorder, Treatment-ResistantDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedNarcotic AntagonistsQuality of LifeSleepTreatment OutcomeBuprenorphineNarcotic Antagonists

Identifiers

PMID25191915
PMCPMC4157317
OpenAlexW2086769768

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.