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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
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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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
•Any clinically significant medical condition that may influence the results of the trial or affect the ability to take part in a trial. •Laboratory screening values considered clinically relevant by a medical doctor for transaminases, thyroid hormones or coagulation parameters •Current or past DSM-IV diagnosis of psychosis, as measured with KSADS-PL •Current treatment with an antipsychotic or mood-stabilising agent •Intake of an antipsychotic or mood-stabilising agent in the two weeks prior to study inclusion •Intake of an antipsychotic agent equivalent to a total haloperidol use of >50 mg in the six months prior to study inclusion •A first-degree relative (i.e. parents, offspring or siblings) participating in this study •UHR diagnosis on the basis of attenuated psychotic symptoms that are entirely explained by acute intoxication •Current aggression or dangerous behaviour (PANSS G14 score 5 or above) •Current suicidality / self-harm (PANSS G6 score 7) •Current DSM-IV diagnosis of alcohol or substance dependence as measured with K-SADS PL •Any current or previous neurological disorder, including epilepsy •History of head injury resulting in unconsciousness lasting at least 1 hour •IQ < 70 •More than 4 weeks of regular omega-3 supplementation (>2 daily capsules standard strength providing >600 mg combined EPA/DHA) within the last 6 months.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University Medical Centre Utrecht (Netherlands) and funded by Stanley Medical Research Institute .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 40629
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