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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.
Early Interv Psychiatry. 2017 10; 11(5):418-428.EI

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.

Authors+Show Affiliations

Orygen, The National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Parkville, Victoria, Australia.Orygen, The National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Parkville, Victoria, Australia.Orygen, The National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Parkville, Victoria, Australia.Orygen, The National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Parkville, Victoria, Australia.Orygen, The National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Parkville, Victoria, Australia.Institute of Brain, Behaviour and Mental Health, University of Manchester, Manchester, UK.Division of Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.Department of Child and Adolescent Psychiatry, University of Zurich, Zurich, Switzerland.Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.Department of Psychiatry and Psychotherapy, University of Jena, Jena, Germany.Academic Psychiatric Centre, AMC, Amsterdam, The Netherlands.Psychiatric University Clinics, University Psychiatric Outpatient Department, Basel, Switzerland.Department of Psychiatry E, Bispebjerg Hospital, Copenhagen, Denmark.Department of Psychiatry, University of Hong Kong, Hong Kong, Hong Kong.Early Psychosis Intervention, Institute of Mental Health, Singapore, Singapore.Brain & Mind Research Institute, University of Sydney, Sydney, New South Wales, Australia.Orygen, The National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, University of Melbourne, Parkville, Victoria, Australia.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

26279065

Citation

Markulev, Connie, et al. "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, 2017, pp. 418-428.
Markulev C, McGorry PD, Nelson B, et al. 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 Interv Psychiatry. 2017;11(5):418-428.
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
Markulev C, et al. 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 Interv Psychiatry. 2017;11(5):418-428. PubMed PMID: 26279065.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. 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, Y1 - 2015/08/16/ PY - 2014/10/27/received PY - 2015/07/02/accepted PY - 2015/8/19/pubmed PY - 2018/3/10/medline PY - 2015/8/18/entrez KW - neuroprotection KW - omega-3 polyunsaturated fatty acid KW - psychosis KW - randomized controlled trial KW - ultra high risk SP - 418 EP - 428 JF - Early intervention in psychiatry JO - Early Interv Psychiatry VL - 11 IS - 5 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. SN - 1751-7893 UR - https://www.unboundmedicine.com/medline/citation/26279065/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_ L2 - https://doi.org/10.1111/eip.12260 DB - PRIME DP - Unbound Medicine ER -