Article

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, Wiley, ISSN 1751-7885

Volume 11, 5, 2017

DOI:10.1111/eip.12260, Dimensions: pub.1002686498, PMID: 26279065,

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  1. (1) University of Melbourne, grid.1008.9
  2. (2) University of Manchester Institute of Brain, Behaviour and Mental Health Manchester UK
  3. (3) University of Warwick, grid.7372.1
  4. (4) University of Zurich, grid.7400.3
  5. (5) Medical University of Vienna, grid.22937.3d
  6. (6) Friedrich Schiller University Jena, grid.9613.d
  7. (7) AMC Academic Psychiatric Centre Amsterdam The Netherlands
  8. (8) University Psychiatric Outpatient Department Psychiatric University Clinics Basel Switzerland
  9. (9) Bispebjerg Hospital, grid.411702.1, Capital Region
  10. (10) University of Hong Kong, grid.194645.b
  11. (11) Institute of Mental Health, grid.414752.1
  12. (12) University of Sydney, grid.1013.3

Description

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.

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Times Cited: 44

Field Citation Ratio (FCR): 21.29

Relative Citation ratio (RCR): 3.23