The NEURAPRO-E: A comparison study of fish oil capsules and psychological therapy versus placebo capsules and psychological therapy in patients at risk of developing a psychotic disorder.


Dataset description

Dataset derived from a clinical research study focusing on the early intervention in the prodromal phase of psychotic disorders, where individuals exhibit symptoms indicative of psychosis but not severe enough to constitute a full disorder. The study involved 320 patients identified as 'ultra high risk' (UHR) for developing psychotic disorders based on established criteria. Participants were randomized to receive either omega-3 fatty acids or a placebo, alongside a standard psychological treatment called cognitive behavioural case management (CBCM). CBCM combines elements of traditional case management with cognitive behavioural therapy, commonly used in clinical settings. The primary objective of this research was to evaluate whether omega-3 fatty acids, against a backdrop of CBCM, can lower the incidence of developing a psychotic disorder among these at-risk individuals.
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FOR: Mental Health |

Source Study


Charities/Societies/Foundations,The Stanley Medical Research Institute

Scientific enquiries

Prof Pat McGorry

Brief Summary

In recent years, researchers of psychotic disorders, a group of mental disorders that involve a loss of contact with reality and symptoms such as hallucinations and delusions, have focused their attention on studying the early phase of psychotic disorders, referred to as the prodromal phase. The prodromal phase is the period of a psychotic disorder where individuals experience the types of symptoms that are indicative of a psychotic disorder but are not yet of the severity or frequency that cons ....
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Key Inclusion Criteria

1. Ability to give informed consent 2. Age 13 - 40 yrs depending on site 3. Membership of one of the following ‘at-risk’ groups: i. Vulnerability (Trait and State Risk Factor) Group: Individuals with a combination of a trait risk factor (Schizotypal personality disorder or a family history of psychotic disorder in a first degree relative) and a significant deterioration in mental state and/or functioning or sustained low functioning during the past year. ii. Attenuated Psychotic Symptoms Group ( ....
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Key Exclusion Criteria

1. Past history of a treated or untreated psychotic episode of one week’s duration or longer. 2. Organic brain disease, e.g. epilepsy, inflammatory brain disease. 3. Abnormal coagulation profile parameters or thyroid function test results >10% above or below the limits of the normal range. 4. Any physical illness with psychotropic effect, if not stabilized. 5. Current treatment with any mood stabiliser, or recreational use of ketamine. 6. Past neuroleptic exposure equivalent to a total lifetime ....
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Can healthy volunteers participate?




Sample Size    304

Min. age    13 Years

Max. age    40 Years

Sex    Both males and females

Condition category    Psychotic disorders.

Condition code    Alternative and Complementary Medicine , Mental Health


Intervention code Behaviour , Treatment: Other

Omega-3 fatty acids, cognitive behavioural case management. Omega-3 fatty acids: 2.8g of marine fish oil containing approximately 1.4g Eicosapentanoic acid (EPA)/Docosahexaenoic acid (DHA) in 4 X 0.700g capsules, administered orally, daily for 6 months. Cognitive behavioural case management: A manualised intervention of cognitive-behavioural therapy (CBT) embedded within case management will be provided to all participants. Participants will receive 6 – 20 sessions within the first 6 months depe ....
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Control group Placebo

Placebo, cognitive behavioural case management. Placebo: The placebo capsules will be matched to the fish oil capsules in size and appearance (4 X 0.700g matched capsules will be administered orally and daily for 6 months). The placebo capsule will contain paraffin/coconut oil, tocopherols to match the content in the active ingredient and a small proportion of the fish oil to ensure the placebo capsules have the same odour as the active capsules. Cognitive behavioural case management: A manualis ....
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Outcome: Rate of transition to first episode psychosis, as determined using the 'Comprehensive Assessment of At Risk Mental States' (CAARMS) instrument.
Timepoint: 6 months. Transition to psychosis will be assessed monthly for the first 6 months, then at 9, 12 and 24 months post entry to the study, as well as at the time of presenting with any symptoms likely to be indicative of transition to psychosis.

Study Protocol: Study protocol
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


What data in particular will be shared?

All individual participant data after de-identification

When will data be available?

Data are available immediately for an indefinite time.

Available to whom?

Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data sharing policy.

Available for what types of analyses?

To any type of analyses. Assessed on a case-by-case basis.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see