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Trial record 9 of 2720 for:    Recruiting, Not yet recruiting Studies | risk

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
Sponsor:
Information provided by (Responsible Party):
Rene Kahn, UMC Utrecht

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ultra High Risk for Psychosis Drug: Omega-3 fatty acids Other: Placebo Not Applicable

Detailed Description:
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 18 sites in 9 countries.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Discontinuation rate [ Time Frame: 2 years ]
  2. Symptomatology [ Time Frame: 2 years ]
    Symptomatology will be examined with the CAARMS.

  3. Psychosocial functioning [ Time Frame: 2 years ]
    As determined by the Social and Occupational Functioning Assessment Scale (SOFAS)

  4. Cognitive function [ Time Frame: 2 years ]
    Cognitive function is determined by the WAIS

  5. 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.

  6. Blood levels of bioactive lipids [ Time Frame: 2 years ]
    Assessment of the omega-3 to omega-6 ratio

  7. 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.

  8. 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.

  9. 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.

  10. Positive and negative symptoms [ Time Frame: 2 years ]
    Symptomatology will be examined with the Positive and Negative Syndrome Scale (PANSS).

  11. Level of functioning [ Time Frame: 2 years ]
    Symptomatology will be examined with the Global Assessment of Functioning scale (GAF).

  12. Clinical Impression [ Time Frame: 2 years ]
    Symptomatology will be examined with the Clinical Global Impression Scale (CGI).

  13. Level of depression [ Time Frame: 2 years ]
    Symptomatology will be examined with the Beck's Depression Inventory (BDI).

  14. Role functioning [ Time Frame: 2 years ]
    Determined by the Global Functioning Role (GF:R) scale

  15. Social functioning [ Time Frame: 2 years ]
    Determined by the Global Functioning Social (GF:S) scale.



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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Matthijs Bossong, Dr +31 (0)88 7556369 M.Bossong@umcutrecht.nl
Contact: Conrad Vissink, Msc +31 (0)88 7553227 c.e.vissink-2@umcutrecht.nl

Locations
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Austria
BioPsyC Biopsychosocial Corporation Recruiting
Vienna, Austria
Contact: Harald Aschauer, Prof. Dr.    +43-664-2445440    harald.aschauer@biopsyc.at   
Germany
Department of Adult Psychiatry, University Hospital Jena Not yet recruiting
Jena, Germany
Contact: Stefan Smesny, Dr.    +49 36419390460    stefan.smesny@med.uni-jena.de   
Department of Child and Adolescent Psychiatry, University of Tübingen Not yet recruiting
Tübingen, Germany
Contact: Tobias Renner, Prof. Dr.    +49 70712982292    tobias.renner@med.uni-tuebingen.de   
Israel
Schneider Children's Medical Center Not yet recruiting
Petach Tikva, Israel
Contact: Alan Apter, Prof.       apter@post.tau.ac.il   
Tel Hashomer The Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: Mark Weiser, Prof. Dr.    +97 235303773    mweiser@netvision.net.il   
Italy
Child Neuropsychiatry Unit, C. Mondino National Neurological Institute Recruiting
Pavia, Italy
Contact: Matteo Chiappedi, MD.       Matteo.chiappedi@unipv.it   
Children Hospital Bambino Gesù Not yet recruiting
Rome, Italy
Contact: Stefano Vicari, Prof. Dr.    +39 6 68592030    stefano.vicari@opbg.net   
Fondazione Santa Lucia Recruiting
Rome, Italy
Contact: Gianfranco Spalletta, MD.    +39 06 51501575    g.spalletta@hsantalucia.it   
Sapienza University of Rome Recruiting
Rome, Italy
Contact: Paolo Fiori Nastro, Prof. Dr.    +39 0640800589    paolo.fiorinastro@uniroma1.it   
Netherlands
Brain Center Rudolf Magnus, Department of Psychiatry, University Medical Center Utrecht Recruiting
Utrecht, Netherlands
Contact: Manon Hillegers, Dr.    +31 88 7556034    M.H.J.Hillegers@umcutrecht.nl   
Norway
Institute of Clinical Medicine, University of Bergen Recruiting
Bergen, Norway
Contact: Rune Andreas Kroken, Ass. prof.    +4755 958400    rune.kroken@helse-bergen.no   
Spain
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain
Contact: Imma Baeza, PhD    +34-932279974    ibaeza@clinic.ub.es   
Hospital Infantil Passeig Sant Joan de Deu Recruiting
Barcelona, Spain
Contact: Montserrat Dolz, Dr.    +34-932804000    mdolz@hsjdbcn.org   
Hospital General Universitario Gregorio Marañon Recruiting
Madrid, Spain
Contact: Covadonga Martínez Díaz-Caneja, Dr.    +34 915867537    covadonga.martinez@iisgm.com   
Idival, University of Cantabria, Cibersam Unidad de investigacion en psiquiatria Recruiting
Santander, Spain
Contact: Bene Crespo-Facorro, Prof. Dr.    +3494 2202545    crespob@unican.es   
Switzerland
ZKJP University Zürich Recruiting
Zurich, Switzerland
Contact: Susanne Walitza, Prof. Dr.    +41 43 499 27 30    susanne.walitza@kjpdzh.ch   
United Kingdom
Psychiatry, Centre for Clinical Brain Sciences Recruiting
Edinburgh, United Kingdom
Contact: Stephen Lawrie, Prof. Dr.    0131-537-6671    s.lawrie@ed.ac.uk   
Sponsors and Collaborators
Rene Kahn

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Responsible Party: Rene Kahn, Prof. dr., UMC Utrecht
ClinicalTrials.gov Identifier: NCT02597439     History of Changes
Other Study ID Numbers: ABR54654
2015-003503-39 ( EudraCT Number )
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018

Keywords provided by Rene Kahn, UMC Utrecht:
Ultra-high risk
UHR
psychosis

Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders