Evidence map›Paper›PMID 39450759›Full record

Trial reportSchizophrenia bulletin2025

Effectiveness of Omega-3 Fatty Acids Versus Placebo in Subjects at Ultra-High Risk for Psychosis: The PURPOSE Randomized Clinical Trial.

Inge Winter-van Rossum, Margot I E Slot, Hendrika H van Hell, Matthijs G Bossong, Gregor Berger, Harald Aschauer, Arija Maat, Susanne Walitza, Orly Lavan, Inmaculada Baeza and 16 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Schizophrenia bulletin, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02597439 (Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe), which is not on this map. Cited by 6 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02597439 phase4completednot on this map

Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe

TypeinterventionalSponsorRene KahnRan2016 to 2023Enrolled145ConditionsUltra High Risk for PsychosisArmsOmega-3 fatty acids, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Inge Winter-van RossumDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands.
Margot I E SlotDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands.ORCID 0000-0003-0420-6922
Hendrika H van HellDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands.
Matthijs G BossongDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands.
Gregor BergerDepartment of Child and Adolescent Psychiatry and Psychotherapy of the Psychiatric University Hospital, University of Zurich, Zurich, Switzerland.
Harald AschauerBioPsyC Biopsychosocial Corporation, Non-profit association for Research Funding Ltd., Vienna, Austria.
Arija MaatDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands.
Susanne WalitzaDepartment of Child and Adolescent Psychiatry and Psychotherapy of the Psychiatric University Hospital, University of Zurich, Zurich, Switzerland.
Orly LavanDepartment of Psychological Medicine, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.
Inmaculada BaezaChild and Adolescent Psychiatry and Psychology Department, SGR2021-01319, Hospital Clínic de Barcelona, Barcelona, Spain.ORCID 0000-0003-2611-5781
Montserrat DolzChild and Adolescent Mental Health Research Group, Institut de Recerca Sant Joan de Déu, Barcelona, Spain.
Elena MonducciHuman Neuroscience, Child and Adolescent Neuropsychiatry, Sapienza University of Rome, Rome, Italy.ORCID 0000-0002-6883-4947
Paolo Fiori NastroDepartment of Human Neuroscience, U.O.D. of Psychotherapy "Villa Tiburtina," Sapienza University of Rome, Rome, Italy.
Rune Andreas KrokenDivision of Psychiatry, Haukeland University Hospital, Bergen, Norway.
Stephen M LawrieDivision of Psychiatry, University of Edinburgh, Edinburgh, Scotland.
Covadonga Martinez Díaz-CanejaDepartment of Child and Adolescent Psychiatry, Institute of Psychiatry and Mental Health, Hospital General Universitario Gregorio Marañón, Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM), CIBERSAM, ISCIII, School of Medicine, Universidad Complutense, Madrid, Spain.ORCID 0000-0001-8538-3175
Tobias RennerDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Tuebingen, Center for Mental Health, University Hospital of Tuebingen, Tuebingen, Germany.
Monika SchlögelhoferBioPsyC Biopsychosocial Corporation, Non-profit association for Research Funding Ltd., Vienna, Austria.
Christian ScharingerBioPsyC Biopsychosocial Corporation, Non-profit association for Research Funding Ltd., Vienna, Austria.
Gianfranco SpallettaLaboratory of Neuropsychiatry, Santa Lucia Foundation IRCCS, Rome, Italy.
Nerisa BanajLaboratory of Neuropsychiatry, Santa Lucia Foundation IRCCS, Rome, Italy.
Soraya OteroChild and Adolescent Psychiatry and Psychology Unit, University Hospital Marques de Valdecilla, Institute of Research Valdecilla Hospital IDIVAL, Santander, Spain.
Maria SchipperDepartment of Datascience and Biostatistics, Julius Center, University Medical Center Utrecht, Utrecht, The Netherlands.
Dorieke Brink- KwakkelDepartment of Datascience and Biostatistics, Julius Center, University Medical Center Utrecht, Utrecht, The Netherlands.
PURPOSE Study Group
Rene S KahnDepartment of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands.

Funding

Neither Stanley Medical Research InstituteStanley Medical Research Institute 14T-002
6 · The paper itself

Abstract

background and hypothesesIn 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

designA 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

resultsThere 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.

conclusionsThis 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).

Indexed as

Fatty Acids, Omega-3Outcome Assessment, Health CareProdromal SymptomsPsychotic DisordersAdolescentAdultDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleRiskYoung AdultFatty Acids, Omega-3nutritionpsychosis preventiontreatment

Identifiers

PMID39450759
PMCPMC12236319

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.