Clinical trial NCT02597439: Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe
Official title: Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ultra High Risk for Psychosis
Keywords: Ultra-high risk
UHR
psychosis
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 145
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Transition rate
timeFrame: 2 years
Secondary outcomes:
measure: Discontinuation rate
timeFrame: 2 years
measure: Symptomatology
timeFrame: 2 years
measure: Psychosocial functioning
timeFrame: 2 years
measure: Cognitive function
timeFrame: 2 years
measure: MRI measures
timeFrame: 2 years
measure: Blood levels of bioactive lipids
timeFrame: 2 years
measure: Tolerability associated with omega-3 fatty acid treatment
timeFrame: 2 years
measure: Blood levels of (epi)genetic markers
timeFrame: 2 years
measure: Blood levels of immune parameters
timeFrame: 2 years
measure: Positive and negative symptoms
timeFrame: 2 years
measure: Level of functioning
timeFrame: 2 years
measure: Clinical Impression
timeFrame: 2 years
measure: Level of depression
timeFrame: 2 years
measure: Role functioning
timeFrame: 2 years
measure: Social functioning
timeFrame: 2 years
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: BioPsyC Biopsychosocial Corporation
city: Tübingen
country: Germany
facility: Department of Child and Adolescent Psychiatry, University of Tübingen
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center
city: Ramat Gan
country: Israel
facility: Tel Hashomer The Sheba Medical Center
city: Rome
country: Italy
facility: Fondazione Santa Lucia
city: Rome
country: Italy
facility: Sapienza University of Rome
city: Utrecht
country: Netherlands
facility: Brain Center Rudolf Magnus, Department of Psychiatry, University Medical Center Utrecht
city: Bergen
country: Norway
facility: Institute of Clinical Medicine, University of Bergen
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Infantil Passeig Sant Joan de Deu
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Santander
country: Spain
facility: Idival, University of Cantabria, Cibersam Unidad de investigacion en psiquiatria
city: Zurich
country: Switzerland
facility: ZKJP University Zürich
city: Edinburgh
country: United Kingdom
facility: Psychiatry, Centre for Clinical Brain Sciences
Study officials:
affiliation: UMC Utrecht
name: René Kahn, Prof. Dr.
role: STUDY_CHAIR
References: