Effectiveness of Omega-3 Fatty Acids Versus Placebo in Subjects at Ultra-High Risk for Psychosis: The PURPOSE Randomized Clinical Trial.
nutrition
psychosis prevention
treatment
Journal
Schizophrenia bulletin
ISSN: 1745-1701
Titre abrégé: Schizophr Bull
Pays: United States
ID NLM: 0236760
Informations de publication
Date de publication:
25 Oct 2024
25 Oct 2024
Historique:
medline:
25
10
2024
pubmed:
25
10
2024
entrez:
25
10
2024
Statut:
aheadofprint
Résumé
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. 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. 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. 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. 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).
Sections du résumé
BACKGROUND AND HYPOTHESES
UNASSIGNED
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
METHODS
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
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
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
RESULTS
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).
Identifiants
pubmed: 39450759
pii: 7841513
doi: 10.1093/schbul/sbae186
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT02597439']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Stanley Medical Research Institute
ID : 14T-002
Organisme : Neither Stanley Medical Research Institute
Investigateurs
Miriam Ayora
(M)
Jill Bjarke
(J)
Linn Marie Elise Aaberg
(LME)
Egil Anders Haugen
(EA)
Valentina Ciullo
(V)
Mauro Ferrara
(M)
Alessia Maffucci
(A)
Valeria Mammarella
(V)
Federica Piras
(F)
Daniela Vecchio
(D)
Margarita Miguel Corredera
(MM)
Jana Gonzalez Gomez
(JG)
Rosa Ayesa-Ariola
(R)
Joaquín Galvañ
(J)
Manuel Durán-Cutilla
(M)
Alan Apter
(A)
Liem Baldinger
(L)
Elena Müller
(E)
Annette Conzelmann
(A)
Gottfried Maria Barth
(GM)
Fabian Probst
(F)
Elena de la Serna
(E)
Gisela Sugranyes
(G)
Adriana Fortea
(A)
Jordina Tor Fabra
(JT)
Elena Aschauer
(E)
Kathrin Kollndorfer
(K)
Klara Györbiro
(K)
Informations de copyright
© The Author(s) 2024. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.