Effectiveness of Omega-3 Fatty Acids Versus Placebo in Subjects at Ultra-High Risk for Psychosis: The PURPOSE Randomized Clinical Trial.
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....
| Publicado en: | Schizophrenia Bulletin Vol. 51; no. 4; pp. 1082 - 1092 |
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| Autores principales: | , , , , , , , , , , , , , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Oxford University Press / USA
Jul2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=186630330&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 186630330 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 05867614 2CZ jtl: Schizophrenia Bulletin issn: 05867614 maglogo: N pubinfo: dt: Jul2025 vid: 51 iid: 4 pid: 622 pub: Oxford University Press / USA artinfo: ui: 186630330 186630330 186630330 10.1093/schbul/sbae186 186630330 ppf: 1082 ppct: 10 formats: tig: atl: Effectiveness of Omega-3 Fatty Acids Versus Placebo in Subjects at Ultra-High Risk for Psychosis: The PURPOSE Randomized Clinical Trial. aug: au: Rossum, Inge Winter-van Slot, Margot I E Hell, Hendrika H van Bossong, Matthijs G Berger, Gregor Aschauer, Harald Maat, Arija Walitza, Susanne Lavan, Orly Baeza, Inmaculada Dolz, Montserrat Monducci, Elena Nastro, Paolo Fiori Kroken, Rune Andreas Lawrie, Stephen M Díaz-Caneja, Covadonga Martinez Renner, Tobias Schlögelhofer, Monika Scharinger, Christian Spalletta, Gianfranco affil: Department of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands sug: subj: Psychotic Disorders Drug Therapy Fatty Acids, omega-3 Therapeutic Use Drug Efficacy Evaluation Human Female Male Adolescence Young Adult Randomized Controlled Trials Random Assignment Double-Blind Studies Placebos Comparative Studies Hospitals, Psychiatric Hospitals, Public Funding Source Descriptive Statistics Data Analysis Software Psychotic Disorders Prevention and Control Europe Israel Psychotic Disorders Risk Factors Adolescent: 13-18 years Female Male 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). pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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