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

NCT02597439 | Completed Phase 4 DMC

• 2 other identifiers: ABR546542015-003503-39
• Study Type: interventional
• Target: 145
• Locations: 9 countries
• Sites: 14

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.

Conditions

Ultra High Risk for Psychosis

Keywords

Ultra-high risk; UHR; psychosis

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (15)

• Discontinuation rate

  2 years

• Symptomatology

  2 years

• Psychosocial functioning

  2 years

• Cognitive function

  2 years

• MRI measures

  2 years

Study Arms (2)

Omega-3 fatty acids

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Omega-3 fatty acids DRUG

Also known as: Fishoil

Omega-3 fatty acids

Placebo OTHER

Placebo

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Rene Kahn: lead

Study Sites (14)

BioPsyC Biopsychosocial Corporation

Vienna, Austria

Location

Department of Child and Adolescent Psychiatry, University of Tübingen

Tübingen, Germany

Location

Schneider Children's Medical Center

Petah Tikva, Israel

Location

Tel Hashomer The Sheba Medical Center

Ramat Gan, Israel

Location

Fondazione Santa Lucia

Rome, Italy

Location

Sapienza University of Rome

Rome, Italy

Location

Brain Center Rudolf Magnus, Department of Psychiatry, University Medical Center Utrecht

Utrecht, Netherlands

Location

Institute of Clinical Medicine, University of Bergen

Bergen, Norway

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Hospital Infantil Passeig Sant Joan de Deu

Barcelona, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Location

Idival, University of Cantabria, Cibersam Unidad de investigacion en psiquiatria

Santander, Spain

Location

ZKJP University Zürich

Zurich, Switzerland

Location

Psychiatry, Centre for Clinical Brain Sciences

Edinburgh, United Kingdom

Location

Related Publications (1)

• Winter-van Rossum I, Slot MIE, van Hell HH, Bossong MG, Berger G, Aschauer H, Maat A, Walitza S, Lavan O, Baeza I, Dolz M, Monducci E, Fiori Nastro P, Kroken RA, Lawrie SM, Diaz-Caneja CM, Renner T, Schlogelhofer M, Scharinger C, Spalletta G, Banaj N, Otero S, Schipper M, Kwakkel DB; PURPOSE Study Group; Kahn RS. Effectiveness of Omega-3 Fatty Acids Versus Placebo in Subjects at Ultra-High Risk for Psychosis: The PURPOSE Randomized Clinical Trial. Schizophr Bull. 2025 Jul 7;51(4):1082-1091. doi: 10.1093/schbul/sbae186.

  PMID: 39450759 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• René Kahn, Prof. Dr.

  UMC Utrecht

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: November 5, 2015
• Study Start: September 30, 2016
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

ES (4); NL (1); AU (1); DE (1); IL (2); IT (2); NO (1); CH (1); GB (1)