NEURAPRO‐E study protocol: a multicentre randomized controlled trial of omega‐3 fatty acids and cognitive‐behavioural case management for patients at ultra high risk of schizophrenia and other psychotic disorders

Media type: E-Article
Title: NEURAPRO‐E study protocol: a multicentre randomized controlled trial of omega‐3 fatty acids and cognitive‐behavioural case management for patients at ultra high risk of schizophrenia and other psychotic disorders
Contributor: Markulev, Connie; McGorry, Patrick D.; Nelson, Barnaby; Yuen, Hok Pan; Schaefer, Miriam; Yung, Alison R.; Thompson, Andrew; Berger, Gregor; Mossaheb, Nilufar; Schlögelhofer, Monika; Smesny, Stefan; de Haan, Lieuwe; Riecher‐Rössler, Anita; Nordentoft, Merete; Chen, Eric Yu Hai; Verma, Swapna; Hickie, Ian; Amminger, G. Paul
Published: Wiley, 2017
Published in: Early Intervention in Psychiatry, 11 (2017) 5, Seite 418-428
Language: English
DOI: 10.1111/eip.12260
ISSN: 1751-7885; 1751-7893
Origination:
Footnote:
Description: <jats:title>Abstract</jats:title><jats:sec><jats:title>Aim</jats:title><jats:p>Recent research has indicated that preventative intervention is likely to benefit patients ‘at‐risk’ for psychosis, both in terms of symptom reduction and delay or prevention of onset of threshold psychotic disorder. The strong preliminary results for the effectiveness of omega‐3 polyunsaturated fatty acids (<jats:styled-content style="fixed-case">PUFA</jats:styled-content>s), coupled with the falling transition rate in ultra high‐risk (<jats:styled-content style="fixed-case">UHR</jats:styled-content>) samples, mean that further study of such benign, potentially neuroprotective interventions is clinically and ethically required. Employing a multicentre approach, enabling a large sample size, this study will provide important information with regard to the use of omega‐3 <jats:styled-content style="fixed-case">PUFAs</jats:styled-content> in the <jats:styled-content style="fixed-case">UHR</jats:styled-content> group.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>This trial is a 6‐month, double‐blind, randomized placebo‐controlled trial of 1.4 g day<jats:sup>−1</jats:sup> omega‐3 <jats:styled-content style="fixed-case">PUFAs</jats:styled-content> in <jats:styled-content style="fixed-case">UHR</jats:styled-content> patients aged between 13 and 40 years. The primary hypothesis is that <jats:styled-content style="fixed-case">UHR</jats:styled-content> patients receiving omega‐3 <jats:styled-content style="fixed-case">PUFAs</jats:styled-content> plus cognitive‐behavioural case management (<jats:styled-content style="fixed-case">CBCM</jats:styled-content>) will be less likely to transition to psychosis over a 6‐month period compared to treatment with placebo plus <jats:styled-content style="fixed-case">CBCM</jats:styled-content>. Secondary outcomes will examine symptomatic and functional changes, as well as examine if candidate risk factors predict response to omega‐3 <jats:styled-content style="fixed-case">PUFA</jats:styled-content> treatment in the <jats:styled-content style="fixed-case">UHR</jats:styled-content> group.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>This is the protocol of the <jats:styled-content style="fixed-case">NeuraproE</jats:styled-content> study. Utilizing a large sample, results from this study will be important in informing indicated prevention strategies for schizophrenia and other psychotic disorders, which may be the strongest avenue for reducing the burden, stigmatization, disability and economic consequences of these disorders.</jats:p></jats:sec>

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