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

Connie Markulev; Patrick D McGorry; Barnaby Nelson; Hok Pan Yuen; Miriam Schaefer; Alison R Yung; Andrew Thompson; Gregor Berger; Nilufar Mossaheb; Monika Schlögelhofer; Stefan Smesny; Lieuwe de Haan; Anita Riecher-Rössler; Merete Nordentoft; Eric Yu Hai Chen; Swapna Verma; Ian Hickie; G Paul Amminger

doi:10.1111/eip.12260

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

Connie Markulev, Patrick D McGorry, Barnaby Nelson, Hok Pan Yuen, Miriam Schaefer, Alison R Yung, Andrew Thompson, Gregor Berger, Nilufar Mossaheb, Monika Schlögelhofer, Stefan Smesny, Lieuwe de Haan, Anita Riecher-Rössler, Merete Nordentoft, Eric Yu Hai Chen, Swapna Verma, Ian Hickie, G Paul Amminger

Department of Clinical Medicine

34 Citations (Scopus)

Abstract

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.

Original language	English
Journal	Early Intervention in Psychiatry
Volume	11
Issue number	5
Pages (from-to)	418-428
Number of pages	11
ISSN	1751-7885
DOIs	https://doi.org/10.1111/eip.12260
Publication status	Published - Oct 2017

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Markulev, C., McGorry, P. D., Nelson, B., Yuen, H. P., Schaefer, M., Yung, A. R., Thompson, A., Berger, G., Mossaheb, N., Schlögelhofer, M., Smesny, S., de Haan, L., Riecher-Rössler, A., Nordentoft, M., Chen, E. Y. H., Verma, S., Hickie, I., & Amminger, G. P. (2017). 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. Early Intervention in Psychiatry, 11(5), 418-428. https://doi.org/10.1111/eip.12260

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. / Markulev, Connie; McGorry, Patrick D; Nelson, Barnaby et al.

In: Early Intervention in Psychiatry, Vol. 11, No. 5, 10.2017, p. 418-428.

Research output: Contribution to journal › Journal article › Research › peer-review

Markulev, C, McGorry, PD, Nelson, B, Yuen, HP, Schaefer, M, Yung, AR, Thompson, A, Berger, G, Mossaheb, N, Schlögelhofer, M, Smesny, S, de Haan, L, Riecher-Rössler, A, Nordentoft, M, Chen, EYH, Verma, S, Hickie, I & Amminger, GP 2017, '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', Early Intervention in Psychiatry, vol. 11, no. 5, pp. 418-428. https://doi.org/10.1111/eip.12260

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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",

abstract = "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.",

author = "Connie Markulev and McGorry, {Patrick D} and Barnaby Nelson and Yuen, {Hok Pan} and Miriam Schaefer and Yung, {Alison R} and Andrew Thompson and Gregor Berger and Nilufar Mossaheb and Monika Schl{\"o}gelhofer and Stefan Smesny and {de Haan}, Lieuwe and Anita Riecher-R{\"o}ssler and Merete Nordentoft and Chen, {Eric Yu Hai} and Swapna Verma and Ian Hickie and Amminger, {G Paul}",

note = "{\textcopyright} 2015 Wiley Publishing Asia Pty Ltd.",

year = "2017",

month = oct,

doi = "10.1111/eip.12260",

language = "English",

volume = "11",

pages = "418--428",

journal = "Early Intervention in Psychiatry",

issn = "1751-7885",

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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

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

SN - 1751-7885

VL - 11

SP - 418

EP - 428

JO - Early Intervention in Psychiatry

JF - Early Intervention in Psychiatry

IS - 5

ER -