Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe

Exclusion Criteria

• •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 K-SADS-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.