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

NCT ID: NCT02597439

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2023-02-01

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.

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.

Conditions

Ultra High Risk for Psychosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Omega-3 fatty acids

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

Omega-3 fatty acids

Intervention Type: DRUG

Placebo

Intervention Type: OTHER

Other Intervention Names

Fishoil

Eligibility 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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rene Kahn

OTHER

Sponsor Role: lead

Responsible Party

Rene Kahn

Prof. dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

René Kahn, Prof. Dr.

Role: STUDY_CHAIR

UMC Utrecht

Locations

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

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

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

Santander, , Spain

ZKJP University Zürich

Zurich, , Switzerland

Psychiatry, Centre for Clinical Brain Sciences

Edinburgh, , United Kingdom

Countries

Austria; Germany; Israel; Italy; Netherlands; Norway; Spain; Switzerland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 39450759 (View on PubMed)

Other Identifiers

2015-003503-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ABR54654

Identifier Type: -

Identifier Source: org_study_id