Double-blind, placebo-controlled trial of mifepristone on cognition and depression in alcohol dependence
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RESEARCH
Open Access
Double-blind, placebo-controlled trial of mifepristone on cognition and depression in alcohol dependence Kim Donoghue1* , Abigail Rose2, Simon Coulton3, Rachel Coleman4, Joanna Milward1, Thomas Philips1,5, Colin Drummond1 and Hilary Little1
Abstract 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. Trial registration: ISRCTN registry ISRCTN54001953. Registered on 29 September 2011. Keywords: Alcohol dependence, Memory, Cognitive function, Depression, Cortisol, Glucocorticoid type II receptor, Mifepristone
* Correspondence: [email protected] 1 Addictions Department, National Addiction Centre, Institute of Psychiatry, King’s College London, 4 Windsor Walk, London SE5 8BB, UK Full list of author information is available at the end of the article © The Author(s). 2020 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless in
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