PURPOSE: Placebo-controlled trial in subjects at Ultra-high Risk for Psychosis with Omega-3 fatty acidS in Europe

Background

Psychosis is a chronic and severe mental disorder, usually preceded by a prodromal phase of attenuated psychotic symptoms and decline in function. Intervention during this prodromal state could prevent transition to psychosis, and is therefore of high significance. A recent randomised controlled trial with individuals at ultra-high risk (UHR) for psychosis showed a significantly lower transition rate to psychosis and reduced psychotic symptoms in those subjects who were treated daily with omega-3 fatty acids compared to placebo. Here we further evaluate the potential of omega-3 fatty acids in the prevention of psychosis.

Objective of PURPOSE

Primary objective of this randomised controlled trial is to compare transition rates to psychosis between individuals who are at UHR for developing psychosis and randomised to treatment with omega-3 fatty acids to those randomised to placebo. Secondary objectives include a comparison between the two treatment arms with regard to discontinuation rate, tolerability, symptomatology, psychosocial and cognitive function, quality of life, blood levels of bioactive lipids, (epi)genetic markers and immune parameters, and brain structure and function as measured with Magnetic Resonance Imaging (MRI). Third, the ability of both MRI and blood parameters to serve as potential biomarkers that may predict clinical response of UHR subjects will be elucidated. Finally, both cross-sectional and longitudinal comparisons of study parameters will be conducted between UHR subjects and healthy controls.

Study design and population

PURPOSE is a European-wide, multicentre, randomised, double-blind, placebo-controlled clinical trial. The study aims to recruit 220 individuals at UHR for psychosis, aged 13 – 20, who will be treated with omega-3 fatty acids or placebo. A limited number of participating centres will additionally recruit a sample of 110 healthy controls without an intervention. UHR subjects are randomised to daily treatment with either 1.2 gram omega-3 polyunsaturated fatty acids or placebo for six months, followed by a 1.5-year clinical follow-up.