The purpose of this study is to determine whether omega-3 fatty acids are effective in the prevention of psychosis in individuals at ultra-high risk for psychosis.
PURPOSE is a randomized double-blind placebo-controlled study. Main objective is to assess the effectivity of omega-3 fatty acid treatment in the prevention of psychosis. The primary outcome measure is the rate of transition to psychosis as determined through CAARMS. Subjects in the age range of 13-20 years with a higher chance of developing psychosis, as determined by the CAARMS, are treated for 6 months with omega-3 fatty acids or placebo. This study in conducted at 14 sites in 9 countries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
145
BioPsyC Biopsychosocial Corporation
Vienna, Austria
Department of Child and Adolescent Psychiatry, University of Tübingen
Tübingen, Germany
Schneider Children's Medical Center
Petah Tikva, Israel
Transition rate
To compare transition rates to psychosis during 2 years of follow-up between the omega-3 fatty acids arm and the placebo arm. Starting point is the first administration of medication at the end of visit 2. Endpoint is the moment that a UHR subject makes a transition to psychosis according to the CAARMS criteria.
Time frame: 2 years
Discontinuation rate
Time frame: 2 years
Symptomatology
Symptomatology will be examined with the CAARMS.
Time frame: 2 years
Psychosocial functioning
As determined by the Social and Occupational Functioning Assessment Scale (SOFAS)
Time frame: 2 years
Cognitive function
Cognitive function is determined by the WAIS
Time frame: 2 years
MRI measures
Brain structure and function are measured in three MRI sessions, consisting of structural MRI, resting state functional MRI, Diffusion Tensor Imaging (DTI), and functional MRI during reward processing.
Time frame: 2 years
Blood levels of bioactive lipids
Assessment of the omega-3 to omega-6 ratio
Time frame: 2 years
Tolerability associated with omega-3 fatty acid treatment
Number of participants with treatment-related adverse events as assessed by the physician.
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Tel Hashomer The Sheba Medical Center
Ramat Gan, Israel
Fondazione Santa Lucia
Rome, Italy
Sapienza University of Rome
Rome, Italy
Brain Center Rudolf Magnus, Department of Psychiatry, University Medical Center Utrecht
Utrecht, Netherlands
Institute of Clinical Medicine, University of Bergen
Bergen, Norway
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Infantil Passeig Sant Joan de Deu
Barcelona, Spain
...and 4 more locations
Time frame: 2 years
Blood levels of (epi)genetic markers
Epigenetic markers of interest include but are not restricted to GAD1 and RELN, which are genes coding for the proteins GAD67 and reelin, respectively.
Time frame: 2 years
Blood levels of immune parameters
Immune parameters that are assessed include but are not restricted to interferon-γ, interleukin (IL)-1α, IL-1RA, IL-5, IL-10, IL12p40, IL-15, IL-18 and tumour necrosis factor-α.
Time frame: 2 years
Positive and negative symptoms
Symptomatology will be examined with the Positive and Negative Syndrome Scale (PANSS).
Time frame: 2 years
Level of functioning
Symptomatology will be examined with the Global Assessment of Functioning scale (GAF).
Time frame: 2 years
Clinical Impression
Symptomatology will be examined with the Clinical Global Impression Scale (CGI).
Time frame: 2 years
Level of depression
Symptomatology will be examined with the Beck's Depression Inventory (BDI).
Time frame: 2 years
Role functioning
Determined by the Global Functioning Role (GF:R) scale
Time frame: 2 years
Social functioning
Determined by the Global Functioning Social (GF:S) scale.
Time frame: 2 years