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Up to 32% of people at ultra-high risk (UHR) develop psychosis — generally, schizophrenia — over 3 years (although the rate has recently declined according to some analyses). In a single-center, randomized, placebo-controlled trial, 3 months of omega-3 polyunsaturated fatty acids (PUFAs) were associated with lower rates of transition to psychosis up to 6 years later (NEJM JW Psychiatry Oct 2015 and Nat Commun 2015; 6:7934). To replicate these results, researchers in an Australian multicenter trial randomized 304 UHR subjects with low or deteriorated functioning in the previous year to 6 months of placebo or PUFAs (1.4 g/day).
All patients also had cognitive-behavioral case management (CBCM; mean, 11 sessions); 62% took antidepressants. Antipsychotic drugs and mood stabilizers were not allowed. Follow-up lasted 6 months, with 26% of participants lost to follow-up.
The primary outcome, transition to psychosis, did not differ between PUFA and placebo (end of treatment: PUFA, 6.7%; placebo, 5.1%; follow-up: PUFA, 11.5%; placebo, 11.2%). Functioning and other symptomatic outcomes also showed no meaningful between-group differences.
McGorry PD et al. Effect of ω-3 polyunsaturated fatty acids in young people at ultrahigh risk for psychotic disorders: The NEURAPRO randomized clinical trial. JAMA Psychiatry 2016 Nov 23; [e-pub]. (http://dx.doi.org/10.1001/jamapsychiatry.2016.2902)
Kane JM and Correll CU.ω-3 polyunsaturated fatty acids to prevent psychosis: The importance of replication studies. JAMA Psychiatry 2016 Nov 23; [e-pub]. (http://dx.doi.org/10.1001/jamapsychiatry.2016.2945)
Comment
As the authors and editorialists note, a low overall transition rate might have been related to concomitant treatment with a psychotherapy that is known to reduce the risk for transition to psychosis, as well as with antidepressants, which can have a similar effect. However, the effect of CBCM is not so great that it could obscure the benefit of PUFA. A subgroup analysis did not support the hypothesis that higher-risk patients would have had a better response. Higher doses might have been beneficial, but as of now there is insufficient evidence that omega-3s reduce the risk of psychosis in UHR individuals.