A world-first, large-scale international trial shows omega-3 fatty acids to be ineffective in preventing the development of psychosis in high risk individuals.
The NEURAPRO trial was designed as a large-scale replication of an original Vienna omega-3 trial lead by Orygen, The National Centre of Excellence in Youth Mental Health which showed 12 weeks of supplementation with omega-3 fatty acids was able to significantly reduce the rate of onset of psychosis in ultra-high risk young people.
The NEURAPRO trial involved 304 young people attending 10 different specialized early psychosis clinics around the world. The participants were randomly assigned to two different groups: one which received 1.4 g of omega-3 fatty acids per day plus psychological treatment, while the second group received placebo plus psychological treatment.
The treatment phase of the trial ran for six months, with a six-month follow-up period after the treatment phase was complete, during which the participants could continue to receive psychological treatment if they wished. Participants were assessed with a range of psychological measures to determine their levels of depression, anxiety and psychotic symptoms, as well as their social and occupational functioning, each month throughout the study.
The research results shows that at the conclusion of the NEURAPRO study, approximately 11% of all participants had gone on to develop psychosis. No difference was seen between the groups who received omega-3 fatty acids and those who received placebo and all participants showed significant improvement in their psychological symptoms.
‘This study has clearly failed to replicate our original findings and there are a number of reasons why this might be the case’ said lead researcher Professor Paul Amminger.
‘These include the fact that all participants received high-quality, intensive psychological support, which in itself may have improved their psychological symptoms and social functioning, preventing any deterioration in their mental health. In addition, antidepressants were given to 62% of participants compared with only 10% in the original study. The high rate of antidepressant treatment could have further contributed to a ceiling effect, and omega-3s did not yield appreciable additional benefits’ Professor Amminger said.
‘Another issue responsible for the lack of efficacy of omega-3 fatty acids was the apparent very low adherence rate; only 42% took 75% or more of the provided capsules. The young people in the replication trial may also have been identified earlier in the course of their illness, and thus been more responsive to the therapies offered, than the young people who participated in our original study’.
‘It is still possible that omega-3 fatty acid treatment is effective in a sub-population of ultra-high risk young people, and that the broader group in our study masked this group. To see if this is the case, we are analysing the levels of omega-3 fatty acids in the blood of each participant, both before and at the end of the treatment phase of the study, to see if they correlate with the young person’s levels of psychiatric symptoms at the beginning and end of the study.’ he said.
Other trials, ongoing analysis of data from the present study, and future research will help to ultimately determine whether Omega-3 fatty acids have a role in the reduction of risk and early treatment of psychotic disorder, the research concludes.
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