Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe (PURPOSE)
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|ClinicalTrials.gov Identifier: NCT02597439|
Recruitment Status : Recruiting
First Posted : November 5, 2015
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ultra High Risk for Psychosis||Drug: Omega-3 fatty acids Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Active Comparator: Omega-3 fatty acids
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.
Drug: Omega-3 fatty acids
Other Name: Fishoil
Placebo Comparator: Placebo
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.
- Transition rate [ Time Frame: 2 years ]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.
- Discontinuation rate [ Time Frame: 2 years ]
- Symptomatology [ Time Frame: 2 years ]Symptomatology will be examined with the CAARMS.
- Psychosocial functioning [ Time Frame: 2 years ]As determined by the Social and Occupational Functioning Assessment Scale (SOFAS)
- Cognitive function [ Time Frame: 2 years ]Cognitive function is determined by the WAIS
- MRI measures [ Time Frame: 2 years ]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.
- Blood levels of bioactive lipids [ Time Frame: 2 years ]Assessment of the omega-3 to omega-6 ratio
- Tolerability associated with omega-3 fatty acid treatment [ Time Frame: 2 years ]Number of participants with treatment-related adverse events as assessed by the physician.
- Blood levels of (epi)genetic markers [ Time Frame: 2 years ]Epigenetic markers of interest include but are not restricted to GAD1 and RELN, which are genes coding for the proteins GAD67 and reelin, respectively.
- Blood levels of immune parameters [ Time Frame: 2 years ]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.
- Positive and negative symptoms [ Time Frame: 2 years ]Symptomatology will be examined with the Positive and Negative Syndrome Scale (PANSS).
- Level of functioning [ Time Frame: 2 years ]Symptomatology will be examined with the Global Assessment of Functioning scale (GAF).
- Clinical Impression [ Time Frame: 2 years ]Symptomatology will be examined with the Clinical Global Impression Scale (CGI).
- Level of depression [ Time Frame: 2 years ]Symptomatology will be examined with the Beck's Depression Inventory (BDI).
- Role functioning [ Time Frame: 2 years ]Determined by the Global Functioning Role (GF:R) scale
- Social functioning [ Time Frame: 2 years ]Determined by the Global Functioning Social (GF:S) scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597439
|Contact: Matthijs Bossong, Dr||+31 (0)88 7556369||M.Bossong@umcutrecht.nl|
|Contact: Conrad Vissink, Msc||+31 (0)88 email@example.com|
|BioPsyC Biopsychosocial Corporation||Recruiting|
|Contact: Harald Aschauer, Prof. Dr. +43-664-2445440 firstname.lastname@example.org|
|Department of Adult Psychiatry, University Hospital Jena||Not yet recruiting|
|Contact: Stefan Smesny, Dr. +49 36419390460 email@example.com|
|Department of Child and Adolescent Psychiatry, University of Tübingen||Not yet recruiting|
|Contact: Tobias Renner, Prof. Dr. +49 70712982292 firstname.lastname@example.org|
|Schneider Children's Medical Center||Not yet recruiting|
|Petach Tikva, Israel|
|Contact: Alan Apter, Prof. email@example.com|
|Tel Hashomer The Sheba Medical Center||Recruiting|
|Ramat Gan, Israel|
|Contact: Mark Weiser, Prof. Dr. +97 235303773 firstname.lastname@example.org|
|Child Neuropsychiatry Unit, C. Mondino National Neurological Institute||Recruiting|
|Contact: Matteo Chiappedi, MD. Matteo.email@example.com|
|Children Hospital Bambino Gesù||Not yet recruiting|
|Contact: Stefano Vicari, Prof. Dr. +39 6 68592030 firstname.lastname@example.org|
|Fondazione Santa Lucia||Recruiting|
|Contact: Gianfranco Spalletta, MD. +39 06 51501575 email@example.com|
|Sapienza University of Rome||Recruiting|
|Contact: Paolo Fiori Nastro, Prof. Dr. +39 0640800589 firstname.lastname@example.org|
|Brain Center Rudolf Magnus, Department of Psychiatry, University Medical Center Utrecht||Recruiting|
|Contact: Manon Hillegers, Dr. +31 88 7556034 M.H.J.Hillegers@umcutrecht.nl|
|Institute of Clinical Medicine, University of Bergen||Recruiting|
|Contact: Rune Andreas Kroken, Ass. prof. +4755 958400 email@example.com|
|Hospital Clinic de Barcelona||Recruiting|
|Contact: Imma Baeza, PhD +34-932279974 firstname.lastname@example.org|
|Hospital Infantil Passeig Sant Joan de Deu||Recruiting|
|Contact: Montserrat Dolz, Dr. +34-932804000 email@example.com|
|Hospital General Universitario Gregorio Marañon||Recruiting|
|Contact: Covadonga Martínez Díaz-Caneja, Dr. +34 915867537 firstname.lastname@example.org|
|Idival, University of Cantabria, Cibersam Unidad de investigacion en psiquiatria||Recruiting|
|Contact: Bene Crespo-Facorro, Prof. Dr. +3494 2202545 email@example.com|
|ZKJP University Zürich||Recruiting|
|Contact: Susanne Walitza, Prof. Dr. +41 43 499 27 30 firstname.lastname@example.org|
|Psychiatry, Centre for Clinical Brain Sciences||Recruiting|
|Edinburgh, United Kingdom|
|Contact: Stephen Lawrie, Prof. Dr. 0131-537-6671 email@example.com|