TY - JOUR

T1 - NEURAPRO-E study protocol

T2 - 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

AU - Markulev, Connie

AU - McGorry, Patrick D

AU - Nelson, Barnaby

AU - Yuen, Hok Pan

AU - Schaefer, Miriam

AU - Yung, Alison R

AU - Thompson, Andrew

AU - Berger, Gregor

AU - Mossaheb, Nilufar

AU - Schlögelhofer, Monika

AU - Smesny, Stefan

AU - de Haan, Lieuwe

AU - Riecher-Rössler, Anita

AU - Nordentoft, Merete

AU - Chen, Eric Yu Hai

AU - Verma, Swapna

AU - Hickie, Ian

AU - Amminger, G Paul

N1 - © 2015 Wiley Publishing Asia Pty Ltd.

PY - 2017/10

Y1 - 2017/10

N2 - AIM: 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 (PUFAs), coupled with the falling transition rate in ultra high-risk (UHR) 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 PUFAs in the UHR group.METHODS: This trial is a 6-month, double-blind, randomized placebo-controlled trial of 1.4 g day(-1) omega-3 PUFAs in UHR patients aged between 13 and 40 years. The primary hypothesis is that UHR patients receiving omega-3 PUFAs plus cognitive-behavioural case management (CBCM) will be less likely to transition to psychosis over a 6-month period compared to treatment with placebo plus CBCM. Secondary outcomes will examine symptomatic and functional changes, as well as examine if candidate risk factors predict response to omega-3 PUFA treatment in the UHR group.CONCLUSION: This is the protocol of the NeuraproE 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.

AB - AIM: 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 (PUFAs), coupled with the falling transition rate in ultra high-risk (UHR) 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 PUFAs in the UHR group.METHODS: This trial is a 6-month, double-blind, randomized placebo-controlled trial of 1.4 g day(-1) omega-3 PUFAs in UHR patients aged between 13 and 40 years. The primary hypothesis is that UHR patients receiving omega-3 PUFAs plus cognitive-behavioural case management (CBCM) will be less likely to transition to psychosis over a 6-month period compared to treatment with placebo plus CBCM. Secondary outcomes will examine symptomatic and functional changes, as well as examine if candidate risk factors predict response to omega-3 PUFA treatment in the UHR group.CONCLUSION: This is the protocol of the NeuraproE 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.

U2 - 10.1111/eip.12260

DO - 10.1111/eip.12260

M3 - Journal article

C2 - 26279065

VL - 11

SP - 418

EP - 428

JO - Early Intervention in Psychiatry

JF - Early Intervention in Psychiatry

SN - 1751-7885

IS - 5

ER -