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.
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.



This trial is a 6-month, double-blind, randomized placebo-controlled trial of 1.4 g day-1omega-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.



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.
Orygen, The National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Parkville, Victoria, Australia.
Connie
C
Markulev
Orygen, The National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Parkville, Victoria, Australia.
Patrick D
PD
McGorry
Orygen, The National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Parkville, Victoria, Australia.
Barnaby
B
Nelson
Orygen, The National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Parkville, Victoria, Australia.
Hok Pan
HP
Yuen
Orygen, The National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Parkville, Victoria, Australia.
Miriam
M
Schaefer
Institute of Brain, Behaviour and Mental Health, University of Manchester, Manchester, UK.
Alison R
AR
Yung
Division of Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.
Andrew
A
Thompson
Department of Child and Adolescent Psychiatry, University of Zurich, Zurich, Switzerland.
Gregor
G
Berger
Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.
Nilufar
N
Mossaheb
Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.
Monika
M
Schlögelhofer
Department of Psychiatry and Psychotherapy, University of Jena, Jena, Germany.
Stefan
S
Smesny
Academic Psychiatric Centre, AMC, Amsterdam, The Netherlands.
Lieuwe
L
de Haan
Psychiatric University Clinics, University Psychiatric Outpatient Department, Basel, Switzerland.
Anita
A
Riecher-Rössler
Department of Psychiatry E, Bispebjerg Hospital, Copenhagen, Denmark.
Merete
M
Nordentoft
Department of Psychiatry, University of Hong Kong, Hong Kong, Hong Kong.
Eric Yu Hai
EYH
Chen
Early Psychosis Intervention, Institute of Mental Health, Singapore, Singapore.
Swapna
S
Verma
Brain & Mind Research Institute, University of Sydney, Sydney, New South Wales, Australia.
Ian
I
Hickie
Orygen, The National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Parkville, Victoria, Australia.
G Paul
GP
Amminger
D000293:Adolescent; D000328:Adult; D019090:Case Management; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage*; D006801:Humans; D038622:Internationality; D011618:Psychotic Disorders / Q000517:prevention & control*; D012307:Risk Factors; D012559:Schizophrenia / Q000517:prevention & control*; D055815:Young Adult
D015525:Fatty Acids, Omega-3
neuroprotection; omega-3 polyunsaturated fatty acid; psychosis; randomized controlled trial; ultra high risk