Evidence map›Paper›PMID 25037206›Full record

Trial reportNeurology2014

Naltrexone for impulse control disorders in Parkinson disease: a placebo-controlled study.

Kimberly Papay, Sharon X Xie, Matthew Stern, Howard Hurtig, Andrew Siderowf, John E Duda, James Minger, Daniel Weintraub

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01052831 (Randomized, Double-blind, Placebo-controlled Study of Naltrexone for Impulse Control Disorders in Parkinson's Disease), which is not on this map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
4.9field-weighted citation impact, top 5% 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.

NCT01052831 phase4completednot on this map

Randomized, Double-blind, Placebo-controlled Study of Naltrexone for Impulse Control Disorders in Parkinson's Disease

TypeinterventionalSponsorUniversity of PennsylvaniaRan2009 to 2012Enrolled50ConditionsImpulse Control Disorder, Parkinson DiseaseArmsNaltrexone, Placebo
3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it, 94 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Trial
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. New pharmacological and neuromodulation approaches for impulsive-compulsive behaviors in Parkinson's disease.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2021
    Review
  14. Developmental Considerations for the Use of Naltrexone in Children and Adolescents.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021
    Article
  15. Review
  16. Management of psychiatric disorders in Parkinson's disease : Neurotherapeutics - Movement Disorders Therapeutics.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2020
    Review
  17. Review
  18. Article
  19. The Neuropsychiatry of Parkinson Disease: A Perfect Storm.The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · 2019
    Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Kimberly PapayFrom the Departments of Psychiatry (K.P., D.W.), Biostatistics and Epidemiology (S.X.X.), and Neurology (M.S., H.H., J.E.D., J.M.), University of Pennsylvania, Philadelphia; Avid Radiopharmaceuticals (A.S.), Philadelphia; and Parkinson's Disease Research, Education and Clinical Center (J.E.D., D.W.), Philadelphia Veterans Affairs Medical Center, PA.
Sharon X XieFrom the Departments of Psychiatry (K.P., D.W.), Biostatistics and Epidemiology (S.X.X.), and Neurology (M.S., H.H., J.E.D., J.M.), University of Pennsylvania, Philadelphia; Avid Radiopharmaceuticals (A.S.), Philadelphia; and Parkinson's Disease Research, Education and Clinical Center (J.E.D., D.W.), Philadelphia Veterans Affairs Medical Center, PA.
Matthew SternFrom the Departments of Psychiatry (K.P., D.W.), Biostatistics and Epidemiology (S.X.X.), and Neurology (M.S., H.H., J.E.D., J.M.), University of Pennsylvania, Philadelphia; Avid Radiopharmaceuticals (A.S.), Philadelphia; and Parkinson's Disease Research, Education and Clinical Center (J.E.D., D.W.), Philadelphia Veterans Affairs Medical Center, PA.
Howard HurtigFrom the Departments of Psychiatry (K.P., D.W.), Biostatistics and Epidemiology (S.X.X.), and Neurology (M.S., H.H., J.E.D., J.M.), University of Pennsylvania, Philadelphia; Avid Radiopharmaceuticals (A.S.), Philadelphia; and Parkinson's Disease Research, Education and Clinical Center (J.E.D., D.W.), Philadelphia Veterans Affairs Medical Center, PA.
Andrew SiderowfFrom the Departments of Psychiatry (K.P., D.W.), Biostatistics and Epidemiology (S.X.X.), and Neurology (M.S., H.H., J.E.D., J.M.), University of Pennsylvania, Philadelphia; Avid Radiopharmaceuticals (A.S.), Philadelphia; and Parkinson's Disease Research, Education and Clinical Center (J.E.D., D.W.), Philadelphia Veterans Affairs Medical Center, PA.
John E DudaFrom the Departments of Psychiatry (K.P., D.W.), Biostatistics and Epidemiology (S.X.X.), and Neurology (M.S., H.H., J.E.D., J.M.), University of Pennsylvania, Philadelphia; Avid Radiopharmaceuticals (A.S.), Philadelphia; and Parkinson's Disease Research, Education and Clinical Center (J.E.D., D.W.), Philadelphia Veterans Affairs Medical Center, PA.
James MingerFrom the Departments of Psychiatry (K.P., D.W.), Biostatistics and Epidemiology (S.X.X.), and Neurology (M.S., H.H., J.E.D., J.M.), University of Pennsylvania, Philadelphia; Avid Radiopharmaceuticals (A.S.), Philadelphia; and Parkinson's Disease Research, Education and Clinical Center (J.E.D., D.W.), Philadelphia Veterans Affairs Medical Center, PA.
Daniel WeintraubFrom the Departments of Psychiatry (K.P., D.W.), Biostatistics and Epidemiology (S.X.X.), and Neurology (M.S., H.H., J.E.D., J.M.), University of Pennsylvania, Philadelphia; Avid Radiopharmaceuticals (A.S.), Philadelphia; and Parkinson's Disease Research, Education and Clinical Center (J.E.D., D.W.), Philadelphia Veterans Affairs Medical Center, PA. daniel.weintraub@uphs.upenn.edu.
Veterans Health Administration · US

Funding

RECRUITMENT COREU19AG010483 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI FELDMAN, HOWARD · 2013 to 2020
$80.6M
Transgenic Mouse Models of Tau PathologiesP01AG017586 · NIA · UNIVERSITY OF PENNSYLVANIA · PI LEE, VIRGINIA M · 2000 to 2021
$37.3M
UPenn ADCC Biomarker CoreP30AG010124 · NIA · UNIVERSITY OF PENNSYLVANIA · PI TROJANOWSKI, JOHN Q. · 1991 to 2020
$35.1M
Project IV: "Alpha-Synuclein Strains & Diverse Synucleinopathies"P50NS053488 · NINDS · UNIVERSITY OF PENNSYLVANIA · PI TROJANOWSKI, JOHN Q. · 2007 to 2017
$20.9M
Statistics and Data Management CoreP50NS071675 · NINDS · FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH · PI FEIGIN, ANDREW · 2010 to 2014
$9.3M
Citalopram Treatment for Agitation in Alzheimer DementiaR01AG031348 · NIA · JOHNS HOPKINS UNIVERSITY · PI LYKETSOS, CONSTANTINE G · 2008 to 2012
$7.9M
TDP-43 Proteinopathies in ALS-DementiaP01AG032953 · NIA · UNIVERSITY OF PENNSYLVANIA · PI LEE, VIRGINIA M · 2010 to 2014
$5.8M
Optimized Arterial Spin Labeling MRI in Mild Cognitive ImpairmentR01AG040271 · NIA · UNIVERSITY OF PENNSYLVANIA · PI WOLK, DAVID A · 2012 to 2016
$2.0M
Long-Term Chamomile Therapy of Generalized Anxiety DisorderR01AT005074 · NCCIH · UNIVERSITY OF PENNSYLVANIA · PI MAO, JUN J · 2009 to 2013
$1.9M
Unbiased Approaches to Novel Biomarker Discovery in Parkinson's DiseaseU01NS082134 · NINDS · UNIVERSITY OF PENNSYLVANIA · PI CHEN-PLOTKIN, ALICE S · 2012 to 2016
$1.8M
Rhodiola rosea Therapy of Major Depressive DisorderR21AT005230 · NCCIH · UNIVERSITY OF PENNSYLVANIA · PI MAO, JUN J · 2010 to 2012
$636k
NCCIH NIH HHS R01-AT005074NCCIH NIH HHS R21-AT005230NIA NIH HHS P01-AG017586NIA NIH HHS P01-AG032953NIA NIH HHS P30 AG010124NIA NIH HHS P30-AG010124NIA NIH HHS R01 AG031348NIA NIH HHS R01-AG040271NIA NIH HHS U19 AG10483-22NINDS NIH HHS (2P50 NS053488NINDS NIH HHS P50-NS053488NINDS NIH HHS P50 NS053488-07A2NINDS NIH HHS P50NS071675-06NINDS NIH HHS U01-NS082134
6 · The paper itself

Abstract

objectiveImpulse control disorders (ICDs) in Parkinson disease (PD) are common and can be difficult to manage. The objective of this study was to determine the efficacy and tolerability of naltrexone, an opioid antagonist, for the treatment of ICDs in PD.

methodsPatients with PD (n = 50) and an ICD were enrolled in an 8-week, randomized (1:1), double-blind, placebo-controlled study of naltrexone 50-100 mg/d (flexible dosing). The primary outcome measure was response based on the Clinical Global Impression-Change score, and the secondary outcome measure was change in symptom severity using the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Rating Scale (QUIP-RS) ICD score.

resultsForty-five patients (90%) completed the study. The Clinical Global Impression-Change response rate difference favoring naltrexone in completers was 19.8% (95% confidence interval [CI] -8.7% to 44.2%). While this difference was not significant (odds ratio=1.6, 95% CI 0.5-5.2, Wald χ2 [df]=0.5 [1], p=0.5), naltrexone treatment led to a significantly greater decrease in QUIP-RS ICD score over time compared with placebo (regression coefficient for interaction term in linear mixed-effects model=-7.37, F[df]=4.3 [1, 49], p=0.04). The estimated changes in QUIP-RS ICD scores from baseline to week 8 were 14.9 points (95% CI 9.9-19.9) for naltrexone and 7.5 points (95% CI 2.5-12.6) for placebo.

conclusionsNaltrexone treatment was not efficacious for the treatment of ICDs in PD using a global assessment of response, but findings using a PD-specific ICD rating scale support further evaluation of opioid antagonists for the treatment of ICD symptoms in PD. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that in patients with PD and an ICD, naltrexone does not significantly increase the probability of achieving response. However, the study lacked the precision to exclude an important difference in response rates.

Indexed as

AgedDisruptive, Impulse Control, and Conduct DisordersDouble-Blind MethodFemaleHumansMaleMiddle AgedNaltrexoneNarcotic AntagonistsParkinson DiseaseNaltrexoneNarcotic Antagonists

Identifiers

PMID25037206
PMCPMC4155050
OpenAlexW2160894339

What OpenQuestion holds

Textmetadata
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.