Antiglucocorticoid augmentation of antiDepressants in Depression (ADD

• Research type

  Research Study

• Full title

  Antiglucocorticoid augmentation of antiDepressants in Depression: a double-blind, randomised, placebo-controlled, parallel-group trial

• IRAS ID

  38766

• Contact name

  Ian Nicol Ferrier

• Sponsor organisation

  Northumberland Tyne & Wear NHS Foundation Trust

• Eudract number

  2009-015165-31

• ISRCTN Number

  45338259

• Research summary

  The study will investigate whether, for patients with depression, adding the drug Metyrapone to an antidepressant is better than using an antidepressant alone. Metyrapone is widely used in the UK for a number of conditions, and works by blocking the production of the stress hormone cortisol, which is thought to decrease the effectiveness of antidepressants. Therefore by blocking cortisol production, it is anticipated that Metyrapone will increase the effectiveness of antidepressants. Patients with depression being treated in primary care or as out-patients in mental health services will be recruited and randomly allocated into one of two groups to receive either Metyrapone or placebo (dummy pills), in addition to their current antidepressant. Neither the research team nor the patient will know which treatment is being taken until the end of the study. 190 patients will be enrolled, aged 18-65 years and diagnosed with a major depressive episode that has not responded adequately to at least two different antidepressant treatments. Metyrapone or placebo will be taken twice a day (12 noon and bedtime) for 21 days. Patients will visit the hospital or clinic for monitoring and assessments of their mood and any side-effects, including completion of a number of questionnaires. They will have some blood tests and collection of saliva samples. Eighty of the enrolled patients and an additional 55 healthy controls, will participate in extra sub-studies to investigate how Metyrapone works. These include extra tests of cognition, electrical activity in the brain (EEG) and Magnetic Resonance Imaging (MRI) scans. These sub-studies will take place in the North East and North West Hubs of the Mental Health Research Network. In the North West, as part of the MRI scan, patients and healthy volunteers will be randomised to be given an injection of either 100mg of hydrocortisone or placebo (salt solution).

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  10/H0904/9

• Date of REC Opinion

  22 Apr 2010

• REC opinion

  Further Information Favourable Opinion