@article{10902/35162,
year = {2024},
url = {https://hdl.handle.net/10902/35162},
abstract = {Background and Hypotheses: In the past 2 decades, substantial effort has been put into research on therapeutic options for people at ultra-high risk (UHR) for developing a first episode of psychosis (FEP), focusing on omega-3 polyunsaturated fatty acids (PUFAs) in preventing transition to psychosis. Despite an initial positive finding, subsequent studies failed to find a beneficial effect. The current study aimed to further investigate the effect of omega-3 PUFAs in UHR, to determine whether this line of research is worth pursuing.
Study Design: A double-blind, randomized, placebo-controlled study testing the efficacy of 6-month treatment with omega-3 PUFAs in 135 subjects at UHR for FEP, aged 13 to 20 years on the prevention of a transition to psychosis, followed up for 18 months post-treatment. The trial was conducted at 16 general hospitals and psychiatric specialty centers located in 8 European countries and Israel.
Study Results: There was no beneficial effect of treatment with omega-3 PUFAs compared to placebo; the rate of transition over 2 years did not differ between treatment arms nor was there a difference in change in symptom severity after 6-month treatment. Dropout rates and serious adverse events were similar across the groups.
Conclusions: This is the third study that fails to replicate the original finding on the protective effect of omega-3 PUFAs in UHR subjects for transition to psychosis. The accumulating evidence therefore suggests that omega-3 PUFAs do not reduce transition rates to psychosis in those at increased risk at 2 years follow-up.},
organization = {This work as supported by the Stanley Medical Research Institute (study code 14T-002) and Burgerstein Vitamine. Neither Stanley Medical Research Institute or Burgerstein Vitamine had any input into the trial design or data analyses. The study was overseen by a Data Safety Monitoring Board (DSMB), an independent board of experts responsible for protecting participant safety and data quality. We are grateful for the involvement and contribution of the DSMB, consisting of the following members: prof. dr. Tyrone Cannon (chair), prof. dr. Pál Czobor and prof. dr. Carmine Pariante. We are grateful for the consultancy by dr. Gregor Berger.},
publisher = {Oxford University Press},
publisher = {Schizophrenia Bulletin, 2024, 186, 1-10},
title = {Effectiveness of Omega-3 fatty acids versus placebo in subjects at ultra-high risk for psychosis: the PURPOSE randomized clinical trial},
author = {Winter-van Rossum, Inge and Slot, Margot I. E. and Van Hell, Hendrika H. and Bossong, Matthijs G. and Berger, Gregor and Aschauer, Harald and Maat, Arija and Walitza, Susanne and Lavan, Orly and Baeza, Inmaculada and Dolz, Montserrat and Monducci, Elena and Nasro, Paolo Fiori and Kroken, Rune Andreas and Lawrie, Stephen and Martínez Díez-Caneja, Covadonga and Renner, Tobias and Schlögelhofer, Monika and Otero Cuesta, María Soraya},
}