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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
Author(s) -
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,
Haan Lieuwe,
RiecherRössler Anita,
Nordentoft Merete,
Chen Eric Yu Hai,
Verma Swapna,
Hickie Ian,
Amminger G. Paul
Publication year - 2017
Publication title -
early intervention in psychiatry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.087
H-Index - 45
eISSN - 1751-7893
pISSN - 1751-7885
DOI - 10.1111/eip.12260
Subject(s) - randomized controlled trial , psychosis , psychiatry , placebo , medicine , schizophrenia (object oriented programming) , cognition , early psychosis , psychological intervention , clinical trial , pediatrics , alternative medicine , pathology
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 ( PUFA s), 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.