PURPOSE
Research type
Research Study
Full title
Placebo-controlled trial in subjects at ultra-high risk for psychosis with omega-3 fatty acids in Europe
IRAS ID
201288
Contact name
Rene Kahn
Contact email
Sponsor organisation
University Medical Center Utrecht
Eudract number
2015-003503-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Psychosis is a chronic and severe mental health disorder characterised by disturbances of thought, perception and cognition. A diagnosis of psychosis is usually preceded by an early phase of subtle or milder psychotic symptoms and a decline in overall functioning. Once these features are present there is a substantially greater risk of developing a psychotic disorder. Therefore, individuals at this stage are regarded to be at Ultra High Risk (UHR) for psychosis. There is a pressing need for treatment interventions at this stage, to reduce the risk of progression to psychosis.
Omega-3 fatty acids or fish oil, is a highly promising intervention as they are known to have important physical health benefits and minimal side effects. A recent clinical trial showed that UHR individuals treated with fish oil showed a significantly lower transition rate to psychosis and reduced psychotic symptoms, in comparison to those treated with placebo.
In order to further evaluate the potential of omega-3 fatty acids in the prevention of psychosis, the current study aims to perform a large, randomised controlled multi-centre trial in Europe. Adolescents who are at high risk for developing psychosis will be treated with fish oil or placebo daily for six months, and clinically followed up for 1.5 years. Participants will be recruited mainly from child and adolescent mental health services, or self-referral from the general population. The study aims to recruit 220 individuals at UHR for psychosis aged 13 – 20, throughout Europe.
REC name
Scotland B REC
REC reference
17/SS/0014
Date of REC Opinion
22 Jun 2017
REC opinion
Further Information Favourable Opinion