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

Donoghue, K, Rose, A, Coulton, S, Coleman, R, Milward, J, Philips, T, Drummond, C and Little, H (2020) Double-blind, placebo-controlled trial of mifepristone on cognition and depression in alcohol dependence. TRIALS, 21 (1). ISSN 1745-6215

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Background: Alcohol 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.
Methods: This 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.
Results: Difficulties 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.
Conclusion: Larger trials would be needed to draw conclusions about the efficacy of mifepristone.

Item Type: Article
Uncontrolled Keywords: Science & Technology; Life Sciences & Biomedicine; Medicine, Research & Experimental; Research & Experimental Medicine; Alcohol dependence; Memory; Cognitive function; Depression; Cortisol; Glucocorticoid type II receptor; Mifepristone; OPEN-LABEL TRIAL; ETHANOL WITHDRAWAL; MOOD; PERFORMANCE; SEVERITY; DRINKING; DEFICITS; BIPOLAR; CORTICOSTEROIDS; IMPAIRMENT; Humans; Alcoholism; Mifepristone; Treatment Outcome; Double-Blind Method; Depression; Cognition; Male; Alcohol dependence; Cognitive function; Cortisol; Depression; Glucocorticoid type II receptor; Memory; Mifepristone; Alcoholism; Cognition; Depression; Double-Blind Method; Humans; Male; Mifepristone; Treatment Outcome; 1102 Cardiorespiratory Medicine and Haematology; 1103 Clinical Sciences; Cardiovascular System & Hematology; General & Internal Medicine
Subjects: B Philosophy. Psychology. Religion > BF Psychology
Divisions: Psychology (from Sep 2019)
Publisher: BMC
SWORD Depositor: A Symplectic
Date Deposited: 16 May 2023 11:29
Last Modified: 16 May 2023 11:29
DOI or ID number: 10.1186/s13063-020-04726-z
URI: https://researchonline.ljmu.ac.uk/id/eprint/19502
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