Evidence map›Paper›PMID 32938477›Full record

Trial reportTrials2020

Double-blind, placebo-controlled trial of mifepristone on cognition and depression in alcohol dependence.

Kim Donoghue, Abigail Rose, Simon Coulton, Rachel Coleman, Joanna Milward, Thomas Philips, Colin Drummond, Hilary Little

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.8field-weighted citation impact, top 33% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 14 citations in OpenAlex.

  1. Drawbacks to Strengthening Neural Salience Encoding: A Link Between Cortisol and Risky Drinking.The Journal of neuroscience : the official journal of the Society for Neuroscience · 2024
    Trial
  2. Article
  3. Review
  4. Review
  5. Review
  6. Article
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 4 institutions in 2 countries.

Kim DonoghueAddictions Department, National Addiction Centre, Institute of Psychiatry, King's College London, 4 Windsor Walk, London, SE5 8BB, UK. kim.donoghue@kcl.ac.uk.ORCID http://orcid.org/0000-0002-7316-1716
Abigail RoseDepartment of Psychological Sciences, University of Liverpool, 2.32, Eleanor Rathbone Building, Bedford Street South, Liverpool, L69 7ZA, UK.
Simon CoultonCentre for Health Service Studies, University of Kent, Canterbury, Kent, CT2 7NF, UK.
Rachel ColemanDepartment of Health Sciences, Seebohm Rowntree Building, University of York, Heslington, York, YO10 5DD, UK.
Joanna MilwardAddictions Department, National Addiction Centre, Institute of Psychiatry, King's College London, 4 Windsor Walk, London, SE5 8BB, UK.
Thomas PhilipsAddictions Department, National Addiction Centre, Institute of Psychiatry, King's College London, 4 Windsor Walk, London, SE5 8BB, UK.
Colin DrummondAddictions Department, National Addiction Centre, Institute of Psychiatry, King's College London, 4 Windsor Walk, London, SE5 8BB, UK.
Hilary LittleAddictions Department, National Addiction Centre, Institute of Psychiatry, King's College London, 4 Windsor Walk, London, SE5 8BB, UK.
King's College London · GBUniversity of Kent · GBUniversity of Liverpool · GBUniversity of York · GB

Funding

Department of Health 13/86/03Department of Health RP-PG-0609-10162Medical Research Council G0701681Medical Research Council G0701818Medical Research Council MR/N00616X/1
6 · The paper itself

Abstract

backgroundAlcohol dependence is a significant issue contributing to disease burden. Changes in cortisol concentrations during alcohol withdrawal are associated with cognitive deficits and symptoms of depression. Current treatments are only successful for a small proportion of people and do not target cognitive deficits and symptoms of depression experienced by those who are alcohol dependent. The aim of this research is to determine the potential efficacy of mifepristone, a type II glucocorticoid receptor antagonist, to prevent symptoms of depression and cognitive deficits following alcohol detoxification.

methodsThis was a phase 2 therapeutic use trial. It was a double-blind randomised controlled clinical trial of mifepristone versus inactive placebo treatment. The trial aimed to recruit 120 participants who met the inclusion criteria: (1) male, (2) aged 18-60 years inclusive, and (3) alcohol dependent for 5 or more years. Participants were randomised to 600 mg a day mifepristone (200 mg morning, afternoon, and evening) for 7 days and 400 mg for the subsequent 7 days (200 mg morning and evening) or the equivalent number of placebo tablets for 14 days. Primary outcome measures were cognitive function (measured using the Cambridge Neuropsychological Test Automated Battery (CANTAB)) and symptoms of depression (measured using the Beck Depression Inventory (BDI)) at 4 weeks post-randomisation.

resultsDifficulties recruiting participants due to significant changes in the provision of inpatient care for alcohol dependence resulted in only 27 participants recruited to the trial, with data available for 21 participants. Fourteen participants were randomised to receive mifepristone and 13 to receive placebo.

conclusionLarger trials would be needed to draw conclusions about the efficacy of mifepristone.

trial registrationISRCTN registry ISRCTN54001953 . Registered on 29 September 2011.

Indexed as

AlcoholismCognitionDepressionDouble-Blind MethodHumansMaleMifepristoneTreatment OutcomeMifepristoneAlcohol dependenceCognitive functionCortisolDepressionGlucocorticoid type II receptorMemoryMifepristone

Identifiers

PMID32938477
PMCPMC7493392
OpenAlexW3084508278

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.