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Contact Information:

Prof Ian Nicol Ferrier
+44 (0)191 2081390
nicol.ferrier@ncl.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Antiglucocorticoid augmentation of antiDepressants in Depression: the ADD study
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Antiglucocorticoid augmentation of antiDepressants in Depression: the ADD study

Not Recruiting

Open to: All Genders

Age: Adult

3.5 Mile Away
Newcastle upon Tyne

Medical Conditions

Major depression

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The aim of this study is to test a drug called metyrapone in patients with moderate to severe depression, as an add-on to current antidepressant treatment. Depression is a common disorder, affecting approximately 10% of the population. The effects can be long-lasting and may recur frequently. Depression has a negative impact on people's quality of life, not only for those who are diagnosed with the condition, but also for their carers. Research has shown that many people with depression also produce more cortisol than is usual. This may stop antidepressant drugs from working properly. The researchers would like to learn whether giving a drug named metyrapone, in addition to a standard antidepressant for a short space of time (three weeks), produces benefits that are meaningful to patients with depression. Previous research on the drug metyrapone has shown that it can block the production of the stress hormone cortisol produced in the body. The ADD study is also designed to see whether any postive effects of metyrapone last beyond the three weeks during which it is given.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Feb 2011 30 Nov 2012

Publications

2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26086063 results2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26727041 results

Participants are randomly allocated to be given either metyrapone or an identical-looking capsule that does not contain any active medicine (a placebo or dummy pill). They continue with their current antidepressant treatment at the same time. Participating in the study involves taking two capsules twice a day, every day for three weeks. The capsules are taken at 12 noon and at bedtime, with milk or after a meal. As this study is 'blinded' it is not possible to tell, until the end of the study, which treatment group patients have been in. Not knowing whether patients are taking metyrapone or placebo does not affect the treatment given at the end of the study. Once recruited into the study, medication is posted to the patient's address of their choice. A prescription is written which is faxed to the Pharmacy based at the Northumberland, Tyne & Wear NHS Foundation Trust, where responsibility lies for dispensing of study medication. Local research teams check participants' progress throughout this treatment period, and for a further 21 weeks afterwards. Mood, general health and social function are assessed. This enables the research teams to understand how patients are feeling during the study and ascertains whether any beneficial effects last over time. Blood samples are taken for routine tests, as well as saliva samples to measure stress hormone levels. With additional permission, a sample is taken for genetic (DNA) analysis. A number of genes have been identified that might be involved in depression. A comparison is made to compare the variations in these genes with the stress hormone level and other tests carried out with how well the drug treatment works to try and understand the reasons for why people vary in their response to treatment. The results are also compared with people who are not depressed (healthy volunteers) to better understand what happens in depression. A sub-group of patients are invited to take part in extra sub-studies investigating the stress system in depression and how metyrapone affects this. Patients may choose to participate in these extra tests which include: computer tests of brain processes such as memory and attention; brain imaging (Magnetic Resonance Imaging; MRI); and electrical recording of brain activity (electroencephalogram; EEG). The aim is to understand more about how stress can cause depression, how treatments may be improved, and if a prediction can be made whether a patient will respond before giving a particular treatment. A separate group of healthy volunteers are also invited to participate in the sub-studies but do not receive metyrapone or placebo treatments.


Patients living in the community and visiting clinics on a regular basis for monitoring of their moderate to severe depression

You can take part if:


Current inclusion criteria as of 05/02/2013:
1. Males and females aged 18-65 years
2. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) confirmed diagnosis of major depression
3. Severity - Patients must have a Hamilton Depression Rating Scale (HDRS17) score of 18 or greater, consistent with a moderate to severe episode. The stability of the patients' clinical state will also be confirmed with a 2 week baseline lead in period (week -2 to 0). A repeat HDRS17 score at time 0 is required to be 18 or greater.
4. Treatment refractoriness - assessed using the Massachusetts General Hospital (MGH) staging method. This defines minimum effective doses of all currently available antidepressants and an "adequate trial" as being for at least 6 weeks. For the trial to be considered as a "failure" it must have been considered by the clinical team to have been ineffective rather than the drug not taken or not tolerated. For inclusion, patients will have failed to have responded to at least their second trial of an antidepressant. This equates to a minimum score of 2 on MGH staging. The maximum MGH score for inclusion in the study will be 10.
5. At trial entry, patients must be taking monotherapy or combination antidepressant therapy that includes a serotonergic drug (a selective serotonin reuptake inhibitor [SSRI], a tertiary amine tricyclic, venlafaxine, duloxetine or mirtazepine). They must not be on noradrenergic antidepressant monotherapy eg. lofepramine, imipramine or reboxitene. At the point of randomisation, patients must have been on their current antidepressant medication, at the current dose, for a minimum of four weeks (protocol amendment approved


You may not be able to take part if:


Current exclusion criteria as of 05/02/2013:1. Any other DSM IV Axis I disorder other than an anxiety disorder unless the depressive episode is considered to be secondary to the anxiety disorder, confirmed using the Structured Clinical interview for DSM (SCID) (protocol amendment approved 15/08/20111)2. Physical co-morbidity which would render the use of metyrapone inappropriate, including untreated hypothyroidism, disorders of steroid production, cardiac failure, angina, myocardial infarction within the last 3 years, renal failure3. Pregnancy - determined by history and if indicated, urine pregnancy test4. Mothers who are breastfeeding 5. Use of concomitant medication that would interfere in a pharmacodynamic or pharmacokinetic manner with metyrapone6. Dependence on alcohol or other drug in the past 12 months and/or current harmful use of alcohol or other drug7. Recently having taken part in another research study that could interfere with the results of this one

Previous exclusion criteria until 05/02/2013:1. Any other DSM IV Axis I disorder2. Physical co-morbidity which would render the use of metyrapone inappropriate, including untreated hypothyroidism, disorders of steroid production, cardiac failure, angina, myocardial infarction within the last 3 years, renal failure3. Pregnancy - determined by history and if indicated, urine pregnancy test4. Mothers who are breastfeeding (Added 21/06/2011)5. Use of concomitant medication that would interfere in a pharmacodynamic or pharmacokinetic manner with metyrapone6. Dependence on alcohol or other drug in the past 12 months and/or current harmful use of alcohol or other drug7. Recently having taken part in another research study that could interfere with the results of this one (Added 21/06/2011)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Newcastle General Hospital
    Newcastle upon Tyne
    NE4 6BE

Metyrapone may improve the symptoms of depression. Participants who take part in studies generally feel better more than participants who don't. This may be down to the more frequent follow-up of patients compared to routine clinical practice. There may be no direct benefit, but participants will help in finding out whether metyrapone is useful in depressed patients and help doctors understand more about the role of stress hormones in this disorder. There is no promise that the study will help current participants, but it may help future patients. There may be side effects of metyrapone; these will be explained in detail by the medical team and included in the patient information sheet. There is a small risk of bruising or discomfort at the injection site when blood samples taken.

Prof Ian Nicol Ferrier
+44 (0)191 2081390
nicol.ferrier@ncl.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Northumberland, Tyne and Wear NHS Foundation Trust (UK) and funded by Medical Research Council; Efficacy and Mechanism Evaluation Programme (ref: EME 08/43/39).



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Read full details for Trial ID: ISRCTN45338259

Or CPMS 7801

Last updated 02 November 2017

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