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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
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Markulev, Connie, McGorry, Patrick D., Nelson, Barnaby, Yuen, Hok Pan, Schaefer, Miriam, Yung, Alison R., Thompson, Andrew D., Berger, Gregor, Mossaheb, Nilufar, Schlögelhofer, Monika, Smesny, Stefan, de Haan, Lieuwe, Riecher-Rössler, Anita, Nordentoft, Merete, Chen, Eric Yu Hai, Verma, Swapna, Hickie, Ian and Amminger, G. Paul (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). pp. 418-428. doi:10.1111/eip.12260 ISSN 1751-7885.
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Official URL: http://dx.doi.org/10.1111/eip.12260
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.
Item Type: | Journal Article | ||||||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Mental Health and Wellbeing Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Journal or Publication Title: | Early Intervention in Psychiatry | ||||||||
Publisher: | Wiley-Blackwell Publishing Ltd. | ||||||||
ISSN: | 1751-7885 | ||||||||
Official Date: | October 2017 | ||||||||
Dates: |
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Volume: | 11 | ||||||||
Number: | 5 | ||||||||
Page Range: | pp. 418-428 | ||||||||
DOI: | 10.1111/eip.12260 | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | Published | ||||||||
Access rights to Published version: | Restricted or Subscription Access |
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