Antiglucocorticoid Augmentation of antiDepressants in Depression
Status:
Completed
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
Depression is one of the most common mental health problems, with at least one in six adults
suffering from this at some time in their life. It can become long-lasting and frequently
recurs. Depression has a large negative impact on quality of life of patients and their
carers and it has also been shown to be one of the leading causes of working age adults
receiving disability payments in the UK. The need for improved treatment has been recognised
by the Department of Health and others. Improvements in drug treatments are therefore
required. There has been recent increased understanding of some of the causes of the frequent
lack of complete response seen with antidepressants. The stress hormone, cortisol, is often
elevated or poorly controlled in depression and there is laboratory and clinical research to
show that this hormonal change reduces the benefits from antidepressants with associated poor
outcome and memory problems. Recently it has been shown in small studies that giving
treatments that reduce cortisol or block its harmful effects for between 1 and 3 weeks
overcome these negative consequences. Our group is particularly interested and experienced in
this topic. The investigators plan to study a drug that decreases cortisol levels in people
who have not recovered with standard antidepressants so that the investigators can find out
the usefulness of this treatment (compared with placebo (dummy tablet)) in day to day life as
well as checking closely for side-effects (the initial studies have shown that the particular
drug the investigators wish to study (metyrapone) has few side effects). The investigators
will also measure cortisol and see if its level can tell us which people do best with this
treatment. The investigators will carry out this study in 3 centres across the UK. The
investigators will carry out some additional tests of specific sorts of memory and decision
making and also do this while scanning the brain (in a painless test). The results of these
tests, along with tests of brain wave patterns, should help us understand more fully how this
new treatment is working and who responds best to it. The study will help us find out if this
drug should be used more widely for people not responding to standard treatments and will
also lead on to the development of other new treatments with an anti-cortisol effect to help
tackle the major problem of poor outcome from depression.
Phase:
Phase 3
Details
Lead Sponsor:
Jane Barnes
Collaborator:
National Institute for Health Research, United Kingdom