TY - JOUR
T1 - Effectiveness of Omega-3 Fatty Acids Versus Placebo in Subjects at Ultra-High Risk for Psychosis
T2 - The PURPOSE Randomized Clinical Trial
AU - Winter-van Rossum, Inge
AU - Slot, Margot I E
AU - van Hell, Hendrika H
AU - Bossong, Matthijs G
AU - Berger, Gregor
AU - Aschauer, Harald
AU - Maat, Arija
AU - Walitza, Susanne
AU - Lavan, Orly
AU - Baeza, Inmaculada
AU - Dolz, Montserrat
AU - Monducci, Elena
AU - Fiori Nastro, Paolo
AU - Kroken, Rune Andreas
AU - Lawrie, Stephen M
AU - Díaz-Caneja, Covadonga Martinez
AU - Renner, Tobias
AU - Schlögelhofer, Monika
AU - Scharinger, Christian
AU - Spalletta, Gianfranco
AU - Banaj, Nerisa
AU - Otero, Soraya
AU - Schipper, Maria
AU - Kwakkel, Dorieke Brink-
AU - Kahn, Rene S
N1 - Publisher Copyright:
© 2024 The Author(s). Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.
PY - 2025/7/7
Y1 - 2025/7/7
N2 - 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.CLINICAL TRIALS: This trial is registered with ClinicalTrials.gov (NCT02597439; Study Details | Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe | ClinicalTrials.gov).
AB - 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.CLINICAL TRIALS: This trial is registered with ClinicalTrials.gov (NCT02597439; Study Details | Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe | ClinicalTrials.gov).
U2 - 10.1093/schbul/sbae186
DO - 10.1093/schbul/sbae186
M3 - Article
C2 - 39450759
SN - 0586-7614
VL - 51
SP - 1082
EP - 1091
JO - Schizophrenia bulletin
JF - Schizophrenia bulletin
IS - 4
ER -