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

Rene Kahn

Status and phase: Completed; Phase 4

Conditions: Ultra High Risk for Psychosis

Treatments: Other: Placebo; Drug: Omega-3 fatty acids

Study type: Interventional

Funder types: Other

Identifiers

NCT02597439

2015-003503-39 (EudraCT Number)

ABR54654

Details and patient eligibility

About

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.

Full 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.

Enrollment: 145 patients

Sex: All

Ages: 13 to 20 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

145 participants in 2 patient groups, including a placebo group

Omega-3 fatty acids

Active Comparator group

Description:

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.

Treatment:

Drug: Omega-3 fatty acids

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo