Antiglucocorticoid Augmentation of antiDepressants in Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

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.
    


Intervention name(s): Metyrapone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 milligrams to be taken twice a day orally; a matched placebo will be administered to patients to take twice a day for 3 weeks
Other intervention name(s): Metyrapone also known as Metopirone
Intervention MeSH terms: Metyrapone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Antiglucocorticoid; Anti-depressants