Although effective therapies are available to many patients with mood disorders in EU countries, their overall prognosis is far from optimal. Thus far, studies identified several underlying pathophysiological domains and a large number of potential predictors of the clinical prognosis of mood disorders. Not only socio-demographic characteristics, clinical psychiatric and somatic features influence the prognosis. It is established that major mood disorders share an immune component to their aetiology, which has a strong impact on the prognosis. Previous EU projects [MOODINFLAME/PSYCHAID] discovered several blood immune biomarkers and immune profiles that characterize major mood disorders. Nevertheless, the integration of all these data to fully understand and predict the prognosis is intricate. Moodstratification will put a new perspective on identifying strong predictors and to enhance our understanding of the pathophysiologic mechanisms of mood disorders. The aim of this study is to establish clinical proof-of-concept of a successful therapy stratification of patients with a mood disorders based on their immune profile. Moodstratification is an international, multi-centre, prospective, open-label trial. It is enrolling 240 MDD and 90 BD ambulant and clinical patients (ages 18-65) from tertiary care clinics. Study – eligible patients have already had prior treatment that has not been sufficiently successful. Baseline assessments include symptoms; daily and social functioning; genetic measures and inflammation markers. A subset of these baseline assessments is repeated after 8 weeks and 24 weeks. Outcomes include the 17-item Hamilton Rating Scale for Depression (primary) and self-reported depressive symptoms, suicidal ideation and anxiety. In the first two years a naturalistic cohort will be monitored while receiving care-as-usual to identify potential predictors and moderators and to develop a stratification model. The second two years will be used to establish proof-of-concept our stratification model.
|Last modified:||11 March 2019 1.34 p.m.|