Effect of ω-3 Polyunsaturated Fatty Acids in Young People at Ultrahigh Risk for Psychotic Disorders: The NEURAPRO Randomized Clinical Trial
Open accessAbstract
IMPORTANCE: A promising treatment to prevent onset and improve outcomes in patients at ultrahigh risk for psychosis is dietary supplementation with long-chain ω-3 polyunsaturated fatty acids (PUFAs). OBJECTIVE: To determine whether treatment with ω-3 PUFAs in combination with a high-quality psychosocial intervention (cognitive behavioral case management [CBCM]) is more effective than placebo plus CBCM. DESIGN, SETTING, AND PARTICIPANTS: NEURAPRO, a double-blind, placebo-controlled, randomized clinical trial, was conducted from March 1, 2010, to September 30, 2014, in 10 specialized early psychosis treatment services in Australia, Asia, and Europe. The primary analysis used the intention-to-treat approach. INTERVENTIONS: A daily dose of 1.4 g of ω-3 PUFAs or placebo (paraffin oil), plus 20 or fewer sessions of CBCM over the 6-month study period. MAIN OUTCOMES AND MEASURES: The primary outcome was transition to psychosis status at 6 months. The secondary outcomes were general levels of psychopathology and functioning, as assessed by the Brief Psychiatric Rating Scale (BPRS) (range, 24-168), Scale for the Assessment of Negative Symptoms (SANS) (range, 0-125), Montgomery-Åsberg Depression Rating Scale (MADRS) (range, 0-60), Young Mania Rating Scale (YMRS) (range, 0-44), Social and Occupational Functioning Assessment Scale (SOFAS) (range, 0-100), and the Global Functioning: Social and Role scale (range, 0-10). For SOFAS and Global Functioning: Social and Role scale, higher scores were better; for other measures, lower scores were better. RESULTS: In this study of 304 adults at ultrahigh risk for psychotic disorders, 153 (50.3%) received ω-3 PUFAs and 151 (49.7%) received placebo. In all, 139 (45.7%) were male; mean (SD) age was 19.1 (4.6) years. The Kaplan-Meier-estimated 6-month transition rates were 5.1% (95% CI, 1.3%-8.7%) in the control group and 6.7% (95% CI, 2.3%-10.8%) in the ω-3 PUFA group. At 12 months, the rates were 11.2% (95% CI, 5.5%-16.7%) in the control group and 11.5% (95% CI, 5.8%-16.9%) in the ω-3 PUFA group. No significant difference was observed between the transition rates of both groups (hazard ratio, 1.1; 95% CI, 0.55-2.23; P = .76, stratified log-rank test). CONCLUSIONS AND RELEVANCE: This trial clearly failed to replicate the findings of the original single-center trial. The most likely explanation is that ω-3 PUFAs lack efficacy under these conditions. However, the lower-than-expected transition rate may have prevented a test of the main hypothesis. Given the substantial symptomatic and functional improvement in both groups, the other treatments received (ie, CBCM and antidepressants) likely produced a ceiling effect beyond which ω-3 PUFAs, even if effective, could not be shown to confer additional benefits. Nevertheless, the main conclusion is that ω-3 PUFAs are not effective under conditions where good quality, evidence-based psychosocial treatment is available. TRIAL REGISTRATION: anzctr.org.au Identifier: 12608000475347.
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The absence of mechanistic models forces researchers to proceed with empirical attempts that may prove unsuccessful, as ultimately happened with omega-3 fatty acids.
“A lack of mechanistic models forces researchers to proceed with empirical attempts that may eventually prove unsuccessful, as has ultimately been the case for omega-3 fatty acids 76 .”
From Lack of evidence to favor specific preventive interventions in psychosis: a network meta‐analysis (2018) · cites this paper as [76]
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- Authors
- McGorry, P. D., Nelson, B., Markulev, C., Yuen, H. P., Schäfer, M. R., Mossaheb, N., Schlögelhofer, M., Smesny, S., Hickie, I. B., Berger, G. E., Chen, E. Y. H., de Haan, L., Nieman, D. H., Nordentoft, M., Riecher-Rössler, A., Verma, S., Thompson, A., Yung, A. R., & Amminger, G. P.
- Affiliations
- The University of Melbourne (AU)
- Medical University of Vienna (AT)
- Jena University Hospital (DE)
- The University of Sydney (AU)
- Kanton Zürich (CH)
- University of Hong Kong (HK)
- Department of Psychiatry, Academic Medical Center, Amsterdam, the Netherlands
- Amsterdam UMC Location University of Amsterdam (NL)
- Bispebjerg Hospital (DK)
- Psychiatric University Clinics Basel, Basel, Switzerland
- Institute of Mental Health (SG)
- University of Warwick (GB)
- University of Manchester (GB)
- Corresponding author
- McGorry, Patrick D.
- ORCID
- Venue
- JAMA Psychiatry
- Publisher
- American Medical Association (AMA)
- Published
- 2017-01-01
- Volume
- 74
- Issue
- 1
- Pages
- 19
- ISSN
- 2168-622X (ISSN-L)
- OpenAlex
- W2551638625
- Cited by
- 262
- References
- 54
- Citations by year
- 2026: 8 · 2025: 13 · 2024: 25 · 2023: 19 · 2022: 14 · 2021: 37 · 2020: 34 · 2019: 54 · 2018: 29 · 2017: 28
- FWCI
- 38.62
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, other-oa)
- Research Explorer (The University of Manchester) (publishedVersion, other-oa)
- Warwick Research Archive Portal (University of Warwick) (acceptedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Own your potential (DEAKIN) (submittedVersion)
- edoc (University of Basel) (submittedVersion)
- Figshare (submittedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (submittedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Zurich Open Repository and Archive (University of Zurich)
- Funders
- Stanley Medical Research Institute (07TGF-1102)
- University of Warwick
- Lundbeckfonden (R155-2014-1724)
- Medical Research Council
- National Health and Medical Research Council (1027532, 566593, 566529, 1060996, 1080963)
- Warwick Medical School
- Topics
- Health Sciences › Nursing › Nutrition and Dietetics › Fatty Acid Research and Health
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
- Keywords
- psychosocial interventions, dietary supplementation, transition to psychosis, negative symptoms, depression, functioning, young adults, omega-3 fatty acids, omega-6 fatty acids, n-6/n-3 ratio, omega-3 index
- MeSH terms
- Adolescent, Adult, Combined Modality Therapy, Double-Blind Method, Female, Humans, Male, Psychotic Disorders, Risk, Cohort Studies, Fatty Acids, Omega-3, Cognitive Behavioral Therapy, Disease Progression, Case Management, Dietary Supplements, Young Adult, Early Medical Intervention
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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