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Association between non-adherence to fish oil or placebo as a risk factor of transition to psychosis in ultra-high-risk individuals in the NEURAPRO study.

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Title: Association between non-adherence to fish oil or placebo as a risk factor of transition to psychosis in ultra-high-risk individuals in the NEURAPRO study.
Authors: Schlögelhofer, Monika (AUTHOR), Lin, Ashleigh (AUTHOR), Markulev, Connie (AUTHOR), Schäfer, Miriam R (AUTHOR), McGorry, Patrick D (AUTHOR), Nelson, Barnaby (AUTHOR), Street, Rebekah (AUTHOR), Mossaheb, Nilufar (AUTHOR), Smesny, Stefan (AUTHOR), Hickie, Ian B (AUTHOR), Berger, Gregor (AUTHOR), Chen, Eric YH (AUTHOR), de Haan, Lieuwe (AUTHOR), Nieman, Dorien H (AUTHOR), Nordentoft, Merete (AUTHOR), Riecher-Rössler, Anita (AUTHOR), Verma, Swapna (AUTHOR), Thompson, Andrew (AUTHOR), Yung, Alison R (AUTHOR), Amminger, G Paul (AUTHOR)
Source: Australian & New Zealand Journal of Psychiatry. Oct2025, Vol. 59 Issue 10, p888-896. 9p.
Subjects: Patient compliance, Risk assessment, Placebos, Research funding, Unsaturated fatty acids, Omega-3 fatty acids, Smoking, Fish oils, Chi-squared test, Kaplan-Meier estimator, Log-rank test, Gas chromatography, Research, Statistics, Mass spectrometry, Drugs, Psychoses, Data analysis software, Cannabis (Genus), Confidence intervals, Proportional hazards models
Abstract: Objective: Non-adherence is an important factor in clinical trials, which has not been investigated in people at ultra-high risk (UHR) of developing a first episode of psychosis. Methods: Exploratory analysis of data from NEURAPRO, a multicenter, placebo-controlled trial of long-chain omega-3 polyunsaturated fatty acids (omega-3 PUFAs) in 304 individuals at UHR. We examined correlates of non-adherence with study medication (omega-3 PUFAs or placebo), including patient, illness and treatment factors, plus transition to psychosis. Non-adherence was defined as <75% study medication intake over 6 months and, post hoc, by the number of returned pills. Results: Of 285 randomized participants with baseline fatty acid data, 163 (57.2%) were non-adherent. In univariate analyses, non-adherence was associated with baseline omega-3 index, pre-baseline duration of untreated symptoms, smoking, cannabis use, lower baseline Social and Occupational Functioning Assessment Scale, Global Functioning: Social and Role Scale scores and transition to psychosis. Transition to psychosis risk was significantly lower in the adherent than non-adherent group (4.2%, 95% CI = 0.7–7.7% vs 17.3%, 95% CI = 10.4–24.2%), Kaplan–Meier Log-rank test, chi-square = 10.675, p = 0.001), independent of omega-3 PUFA treatment status. Similarly, Cox regression analysis, covarying for the aforementioned factors significantly associated with non-adherence, also revealed non-adherence as an independent predictor of transition to psychosis (B = 1.452, p = 0.005). Finally, non-adherence was also significantly associated with transition to psychosis, even when defining non-adherence by number of returned pills. Conclusion: Non-adherence predicted a higher risk of progressing to psychosis in UHR individuals. Further studies are needed to better understand factors contributing to non-adherence and how non-adherence is related to transition to psychosis. [ABSTRACT FROM AUTHOR]
Copyright of Australian & New Zealand Journal of Psychiatry is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: Psychology and Behavioral Sciences Collection
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  Data: Association between non-adherence to fish oil or placebo as a risk factor of transition to psychosis in ultra-high-risk individuals in the NEURAPRO study.
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  Data: Objective: Non-adherence is an important factor in clinical trials, which has not been investigated in people at ultra-high risk (UHR) of developing a first episode of psychosis. Methods: Exploratory analysis of data from NEURAPRO, a multicenter, placebo-controlled trial of long-chain omega-3 polyunsaturated fatty acids (omega-3 PUFAs) in 304 individuals at UHR. We examined correlates of non-adherence with study medication (omega-3 PUFAs or placebo), including patient, illness and treatment factors, plus transition to psychosis. Non-adherence was defined as &lt;75% study medication intake over 6 months and, post hoc, by the number of returned pills. Results: Of 285 randomized participants with baseline fatty acid data, 163 (57.2%) were non-adherent. In univariate analyses, non-adherence was associated with baseline omega-3 index, pre-baseline duration of untreated symptoms, smoking, cannabis use, lower baseline Social and Occupational Functioning Assessment Scale, Global Functioning: Social and Role Scale scores and transition to psychosis. Transition to psychosis risk was significantly lower in the adherent than non-adherent group (4.2%, 95% CI = 0.7–7.7% vs 17.3%, 95% CI = 10.4–24.2%), Kaplan–Meier Log-rank test, chi-square = 10.675, p = 0.001), independent of omega-3 PUFA treatment status. Similarly, Cox regression analysis, covarying for the aforementioned factors significantly associated with non-adherence, also revealed non-adherence as an independent predictor of transition to psychosis (B = 1.452, p = 0.005). Finally, non-adherence was also significantly associated with transition to psychosis, even when defining non-adherence by number of returned pills. Conclusion: Non-adherence predicted a higher risk of progressing to psychosis in UHR individuals. Further studies are needed to better understand factors contributing to non-adherence and how non-adherence is related to transition to psychosis. [ABSTRACT FROM AUTHOR]
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  Data: &lt;i&gt;Copyright of Australian &amp; New Zealand Journal of Psychiatry is the property of Sage Publications Inc. and its content may not be copied or emailed to multiple sites without the copyright holder&#39;s express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.&lt;/i&gt; (Copyright applies to all Abstracts.)
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        Value: 10.1177/00048674251361758
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