Double-blind, placebo-controlled trial of mifepristone on cognition and depression in alcohol dependence
Year: 2020
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Source: Trials
Language: English
Subfield: Neurology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,190
Funders: South London and Maudsley NHS Foundation Trust, King's College Hospital NHS Foundation Trust, National Institute for Health and Care Research, King's College London, Medical Research Council, Collaboration for Leadership in Applied Health Research and Care - Greater Manchester, National Institute for Health Research Applied Research Collaboration South London
Awards: G1874996804, NIHR Senior Investigator Award, G3376147854, Developing and evaluating interventions for adolescent alcohol use disorders presenting through emergency departments, The effectiveness of adjunctive Medication Management and Contingency Management to enhance adherence to medications for relapse prevention in alcohol dependence
OpenAlex ID: W3084508278