Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe (PURPOSE)
Ultra High Risk for Psychosis
About this trial
This is an interventional prevention trial for Ultra High Risk for Psychosis focused on measuring Ultra-high risk, UHR, psychosis
Eligibility Criteria
Inclusion Criteria:
- Written informed consent of the subject. For individuals younger than 18 years of age the parents / legal representatives need to give consent, and the subject can provide assent (whether the latter is required depends on local laws and regulations).
- UHR diagnosis as made using the Comprehensive Assessment of At-Risk Mental States (CAARMS) (Yung et al., 2005). Subjects have to meet one or more of the following criteria: (a) attenuated psychotic symptoms, (b) brief limited intermittent psychotic symptoms (a history of one or more episodes of frank psychotic symptoms that resolved spontaneously within 1 week in the past year), or (c) either the presence of schizotypal personality disorder or a family history of psychosis in a first-degree relative, all three together with a recent decline in function.
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.
Sites / Locations
- BioPsyC Biopsychosocial Corporation
- Department of Child and Adolescent Psychiatry, University of Tübingen
- Schneider Children's Medical Center
- Tel Hashomer The Sheba Medical Center
- Fondazione Santa Lucia
- Sapienza University of Rome
- Brain Center Rudolf Magnus, Department of Psychiatry, University Medical Center Utrecht
- Institute of Clinical Medicine, University of Bergen
- Hospital Clinic de Barcelona
- Hospital Infantil Passeig Sant Joan de Deu
- Hospital General Universitario Gregorio Marañon
- Idival, University of Cantabria, Cibersam Unidad de investigacion en psiquiatria
- ZKJP University Zürich
- Psychiatry, Centre for Clinical Brain Sciences
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Omega-3 fatty acids
Placebo
Subjects will be treated daily with 1.2 gram omega-3 polyunsaturated fatty acids (720 mg eicosapentaenoic acid (EPA) and 480 mg Docosahexaenoic acid(DHA)) for six months.
Subjects will be treated daily with placebo for six months. Placebo capsules will contain a 1:1 combination of coconut oil and medium chain triglycerides because these do not contain polyunsaturated fatty acids and have no impact on omega-3 fatty acid metabolism. Placebo capsules also contain the same amount of vitamin E as the omega-3 capsules and 1% fish oil to mimic flavour and taste.