Extrait

Background and study aims Depression is a common and disabling mental disorder. The number of people with depression is increasing in the developed world, which has been linked to lifestyle. The most common treatments fail to solve all cases, and there is a significant percentage of depressed patients who respond poorly to these treatments. Hygienic and dietary measures have proven effective when used in conjunction with standard treatments. However, this combination has not yet been proven to be effective in routine clinical practice conditions. We are carrying out a study of 300 major depression patients to test the effect of antidepressants combined with structured hygienic and dietary recommendations in primary care. Who can participate? Adult patients who have depression, can understand spoken and written Spanish and are able to give written informed consent to take part in the study. What does the study involve? The patient will be assigned randomly one of two groups: a) hygienic-dietary recommendations b) unspecific hygienic-dietary recommendations (control group) Depression, quality of life and consumption of health and social services scales will be administered. What are the possible benefits and risks of participating? There is no guarantee that patients participating in this study have a benefit. We hope that one of the two groups have better outcomes in terms of depressive symptoms than the other, but there are no expected side effects or safety issues. Where is the study run from? From three research centers of three Spanish cities: Universitat Illes Balears in Palma de Mallorca Grupo Aragonés de Investigación en Salud Mental in Zaragoza Parc Sanitari Sant Joan de Deu in Barcelona When is study starting and how long is it expected to run for? Recruitment will begin in September 2012 and data collection is expected to end in December 2013 Who is funding the study? Instituto de Salud Carlos III (Spanish Government) Who is the main contact? Professor Mauro Garcia-Toro [email protected]

Critère d'inclusion

• Major depression

Liens

• isrctn
• ictrp