World Mental Health Day: 10 October 2013
The European Medicines Agency is supporting World Mental Health Day, which takes place on 10 October 2013.
The Agency plays a role in the authorisation of medicines to treat mental-health illnesses and has recommended the authorisation of a number of such medicines in the European Union (EU).
The Agency also publishes guidelines describing how studies of medicines for the treatment of mental disorders should be designed and carried out. Such guidelines are intended to help the pharmaceutical industry and public institutions carry out clinical research in this domain. These guidelines are developed by the Agency’s Central Nervous System Working Party (CNSWP), which is composed of European experts selected from or associated with the EU national medicines agencies.
The CNSWP is currently developing the first European guideline for the clinical evaluation of medicines for the treatment of autism, an area where there is a significant unmet medical need. Since autism is a life-long condition, new treatments have to be evaluated in all age groups and long-term safety data need to be generated. The guidance will cover diagnostic criteria, definition of target treatment populations, efficacy criteria, specific age-category problems (childhood versus adulthood), and the need for comparative studies.
In the area of depression, a revised guideline on the clinical investigation of medicines for the treatment of depression, which focuses on antidepressants for major depressive disorder (MDD), was published in May 2013. The revised guideline addresses specific issues related to treatment-resistant patients and those who only respond partially to treatment, who represent a large proportion of patients with MDD.
The Agency also helps companies in their research and development of new medicines by issuing opinions on the acceptability of using a specific method, such as an imaging method or a biomarker in their medicines development programme.
Since 2011, the Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted four of these qualification opinions for use in the development of medicines for the treatment of Alzheimer’s disease. Most of these opinions are for biomarkers that can help identify and select patients at the pre-dementia stage of the disease for clinical investigation.
In the diagnostic area, the first radiopharmaceutical for positron-emission-tomography (PET) imaging of beta-amyloid neuritic plaques in the brain (Amyvid) was approved by the European Commission in January 2013 on the recommendation of the CHMP. This diagnostic agent can be used in patients who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. Two other diagnostic radiopharmaceuticals for Alzheimer’s disease (florbetaben (18F) and flutemetamol (18F)) are currently under evaluation by the CHMP.
About World Mental Health Day
World Mental Health Day 2013 is focusing on mental disorders in the elderly, including dementia and depression, and aims to encourage governments and organisations around the world to look at the mental-health issues experienced by older people in their communities and to consider their need for support and services.
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- World Mental Health Day
- Global Alliance of Mental Illness Advocacy Networks-Europe
- European Medicines Agency recommends approval of first radiopharmaceutical for PET imaging of β-amyloid neuritic plaque density (19/10/2012)