Ultra High Risk for PsychosisPhase 4PURPOSENCT02597439
Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe
A Phase 4 study testing Omega-3 fatty acids in people with Ultra High Risk for Psychosis, run by Rene Kahn at 14 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Ultra High Risk for Psychosis
- What is being tested?
- Omega-3 fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 14 sitesin 9 countries
- Study dates
- 30 Sep 2016to 1 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
14 sites in 9 countries.
14 sites in 9 countries
Spain4 sites
Hospital Clinic de Barcelona
Barcelona
Hospital Infantil Passeig Sant Joan de Deu
Barcelona
Hospital General Universitario Gregorio Marañon
Madrid
Idival, University of Cantabria, Cibersam Unidad de investigacion en psiquiatria
Santander
Israel2 sites
Schneider Children's Medical Center
Petah Tikva
Tel Hashomer The Sheba Medical Center
Ramat Gan
Germany1 site
Department of Child and Adolescent Psychiatry, University of Tübingen
Tübingen
Netherlands1 site
Brain Center Rudolf Magnus, Department of Psychiatry, University Medical Center Utrecht
Utrecht
United Kingdom1 site
Psychiatry, Centre for Clinical Brain Sciences
Edinburgh
About this study
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.
Read the 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
- Being tested
- Omega-3 fatty acids, Placebo
- Keywords
- Ultra-high risk, UHR, psychosis
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acidsDrug
Also called Fishoil
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (15)
Discontinuation rate
Measured: 2 years
Symptomatology
Symptomatology will be examined with the CAARMS.
Measured: 2 years
Psychosocial functioning
As determined by the Social and Occupational Functioning Assessment Scale (SOFAS)
Measured: 2 years
Cognitive function
Cognitive function is determined by the WAIS
Measured: 2 years
MRI measures
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.
Measured: 2 years
Blood levels of bioactive lipids
Assessment of the omega-3 to omega-6 ratio
Measured: 2 years
Tolerability associated with omega-3 fatty acid treatment
Number of participants with treatment-related adverse events as assessed by the physician.
Measured: 2 years
Blood levels of (epi)genetic markers
Epigenetic markers of interest include but are not restricted to GAD1 and RELN, which are genes coding for the proteins GAD67 and reelin, respectively.
Measured: 2 years
Blood levels of immune parameters
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.
Measured: 2 years
Positive and negative symptoms
Symptomatology will be examined with the Positive and Negative Syndrome Scale (PANSS).
Measured: 2 years
Level of functioning
Symptomatology will be examined with the Global Assessment of Functioning scale (GAF).
Measured: 2 years
Clinical Impression
Symptomatology will be examined with the Clinical Global Impression Scale (CGI).
Measured: 2 years
Level of depression
Symptomatology will be examined with the Beck's Depression Inventory (BDI).
Measured: 2 years
Role functioning
Determined by the Global Functioning Role (GF:R) scale
Measured: 2 years
Social functioning
Determined by the Global Functioning Social (GF:S) scale.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study start30 Sep 2016
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ultra High Risk for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rene Kahn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rene Kahn, UMC Utrecht
- Investigators
- René Kahn, Prof. Dr., Study chair, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02597439
- Sponsor's protocol ID
- ABR54654
- Other IDs
- 2015-003503-39, 2015
- Acronym
- PURPOSE
- Status last verified
- Feb 2023
- First submitted
- 15 Oct 2015
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 39450759
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe
- ClinicalTrials.gov ID
- NCT02597439
- Acronym / sponsor ID
- PURPOSE / ABR54654
- Conditions
- Ultra High Risk for Psychosis
- Keywords
- Ultra-high risk, UHR, psychosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Rene KahnUniversity, hospital or other
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 fatty acids | Active comparator | Drug: Omega-3 fatty acidsSubjects 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. |
| Placebo | Placebo comparator | Other: PlaceboSubjects 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. |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acidsAlso: Fishoil | Drug | Omega-3 fatty acids |
| Placebo | Other | Placebo |
Primary outcome
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.
15 secondary outcomes
Discontinuation rate
Time frame: 2 years
Symptomatology
Time frame: 2 years
Psychosocial functioning
Time frame: 2 years
Cognitive function
Time frame: 2 years
MRI measures
Time frame: 2 years
Blood levels of bioactive lipids
Time frame: 2 years
Tolerability associated with omega-3 fatty acid treatment
Time frame: 2 years
Blood levels of (epi)genetic markers
Time frame: 2 years
Blood levels of immune parameters
Time frame: 2 years
Positive and negative symptoms
Time frame: 2 years
Level of functioning
Time frame: 2 years
Clinical Impression
Time frame: 2 years
Level of depression
Time frame: 2 years
Role functioning
Time frame: 2 years
Social functioning
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Derived from this study: PubMed 39450759Winter-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René Kahn, Prof. Dr. study chair
UMC Utrecht
14 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega-3 fatty acids in people with Ultra High Risk for Psychosis, run by Rene Kahn at 14 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain, Israel, Italy, Austria, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transition rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02597439, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.