Indicated prevention with long-chain polyunsaturated omega-3 fatty acids in patients with 22q11DS genetically at high risk for psychosis. Protocol of a randomized, double-blind, placebo-controlled treatment trial.

[22q11.2 deletion syndrome]

It has been found that long -chain omega-3 polyunsaturated fatty acids (PUFAs ) reduce the risk of progression to first episode of psychosis (FEP ) and may offer a safe and efficacious strategy for selective and indicated prevention in young people with ultra-high -risk (UHR ) states . An opportunity for exploring the trajectory of FEP and for investigating the efficacy of preventive treatments exists in 22 q 11 .2 deletion syndrome (22 q 11 DS ), which has a 30 % psychotic transition rate . The fact that 22 q 11 DS patients are more homogeneous than other UHR groups and are characterized by high level of negative symptoms provides a strong rationale for the use of PUFAs . The principal aim of the present trial is to investigate the effects of PUFAs in individuals with 22 q 11 DS who are at UHR for developing FEP .A prospective , randomized , double -blind , placebo-controlled , single -centre study design will be used . Eighty individuals aged 12 -26 will be randomly assigned to two treatment conditions .The experimental group will receive PUFAs . The placebo group will receive paraffin oil . Standard clinical assessments and neuropsychological tests will be performed at baseline and at 8 -, 12 -, 26 - and 52 -week follow-up . Blood samples will be collected at baseline and after 12 weeks . This study is registered as an International Standard RCT , number 02070211 . The corresponding author is supported by a NARSAD Young Investigator Award .T his is the protocol of a planned study that aims to test the efficacy of PUFAs in the prodromal phase of FEP , in a specific syndrome where there is strong evidence that a high genetic load is involved in the disorder .