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

Trials

Hilary Little¹  Kim Donoghue¹  Colin Drummond¹  Joanna Milward¹  Thomas Philips²  Simon Coulton³  Rachel Coleman⁴  Abigail Rose⁵ 

[1] Addictions Department, National Addiction Centre, Institute of Psychiatry, King’s College London, 4 Windsor Walk, SE5 8BB, London, UK;Addictions Department, National Addiction Centre, Institute of Psychiatry, King’s College London, 4 Windsor Walk, SE5 8BB, London, UK;Institute for Clinical and Applied Health Research, Allam Medical Building,, University of Hull, HU6 7RX, Hull, UK;Centre for Health Service Studies, University of Kent, CT2 7NF, Canterbury, Kent, UK;Department of Health Sciences, Seebohm Rowntree Building, University of York, Heslington, YO10 5DD, York, UK;Department of Psychological Sciences, University of Liverpool, 2.32, Eleanor Rathbone Building, Bedford Street South, L69 7ZA, Liverpool, UK;

关键词: Alcohol dependence;    Memory;    Cognitive function;    Depression;    Cortisol;    Glucocorticoid type II receptor;    Mifepristone;   

DOI  :  10.1186/s13063-020-04726-z

来源: Springer

【 摘 要 】

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.

【 授权许可】

CC BY