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Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe | Clinical Trials | Clareo Health

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

NCT02597439•Rene Kahn

View on ClinicalTrials.gov

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.

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 14 sites in 9 countries.

Eligibility

Age

13 - 20 years

Sex

ALL

Healthy Volunteers

Yes

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)
+5 more criteria

Locations (14)

BioPsyC Biopsychosocial Corporation

Vienna, Austria

Department of Child and Adolescent Psychiatry, University of Tübingen

Tübingen, Germany

Schneider Children's Medical Center

Petah Tikva, Israel

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

Key Dates

Start Date

September 30, 2016

Primary Completion Date

February 1, 2023

Completion Date

February 1, 2023

Last Updated

February 14, 2023

Enrollment

145

ACTUAL participants

Conditions

Ultra High Risk for Psychosis

Interventions

Omega-3 fatty acids

DRUG

Placebo

OTHER

Sacramento Clinical High Risk for Psychosis Stepped-Care Program

NCT06640803

Clinical High Risk for PsychosisUltra High Risk for Psychosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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