Add-on Therapie mit Omega-3 Fettsäuren bei Jugendlichen mit hohem Risikofür Schizophrenie und andere psychotische Störungen: eine Multizentren-ReplikationsstudieOmega-3 Fatty Acids for Symptomatic Patients at Ultra-High Risk for Early Progression to Schizophrenia and Other Psychotic Disorders: A Multicentre ReplicationStudy - Omega-3 fatty acids for indicated prevention of psychotic disorders

• Conditions: In view of recent data and after a careful review of potentially neuroprotective treatment options in early psychotic illness, we have decided to replicate the findings of a randomized controlled trial of Amminger et al. (ClinicalTrials.gov, number NCT00396643) studying the efficacy of omega-3 fatty acids (EPA/DHA) in young patients at ultra-high-risk for psychosis preventing the onset of schizophrenia or other psychotic disorders.

• Registration Number: EUCTR2008-005004-13-AT
• Lead Sponsor: Orygen Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Inclusion criteria

A. General inclusion criteria:
i. Ability to give informed consent
ii. Age 13-25 years

B. Membership of one of the following three ‘at-risk’ groups:
i. Attenuated Psychotic Symptoms Group (APS) Individuals with subthreshold (intensity or frequency) positive psychotic symptoms. The symptoms must have been present during the past year and be associated with a significant reduction in functioning.
ii. Brief Limited Intermittent Psychotic Symptoms Group (BLIPS) Individuals with a recent history of frank psychotic symptoms that resolved spontaneously (without antipsychotic medication) within one week. The symptoms must have been present during the past year and be associated with a significant reduction in functioning.
iii. Trait and State Risk Factor Group Individuals with a combination of a trait risk factor (such as schizotypal personality disorder or a family history of psychotic disorder in a first degree relative) and a significant deterioration in mental state and/or functioning for at least one month at the time of intake. Operationalized intake criteria based on the Comprehensive Assessment of At-Risk Mental State (CAARMS; Yung et al, 1998) are presented in Table 1.

Table 1: Operationalized intake criteria
Group 1: Attenuated Psychotic Symptoms Group
1a) Subthreshold intensity:
Intensity: Severity Scale Score of 3-5 on Disorders of Thought Content subscale, 3-4 on Perceptual Abnormalities subscale and/or 4-5 on Disorganised Speech subscales of the CAARMS
Frequency: Frequency Scale Score of 3-6 on Disorders of Thought Content, Perceptual Abnormalities and/or Disorganised Speech subscales of the CAARMS
Duration : symptoms present for at least one week
Recency: symptoms present in past year
Impact: SOFAS score currently and for the last month a at least 30% below previous level of functioning .
1b) Subthreshold frequency:
Intensity: Severity Scale Score of 6 on Disorders of Thought Content subscale, 5-6 on Perceptual Abnormalities subscale and/or 6 on Disorganised Speech subscales of the CAARMS
Frequency: Frequency Scale Score of 3 on Disorders of Thought Content, Perceptual Abnormalities and/or Disorganised Speech subscales of the CAARMS
Duration: symptoms present for at least one week
Recency: symptoms present in past year
Impact: SOFAS score currently and for the last month a at least 30% below previous level of functioning .

Group 2: BLIPS Group
Intensity: Severity Scale Score of 6 on Disorders of Thought Content subscale, 5 or 6 on Perceptual Abnormalities subscale and/or 6 on Disorganised Speech subscales of the CAARMS
Frequency: Frequency Scale Score of 4-6 on Disorders of Thought Content, Perceptual Abnormalities and/or Disorganised Speech subscales
Duration: Symptoms present for less than one week and spontaneously remit.
Recency: symptoms present in past year
Impact: SOFAS score currently and for the last month a at least 30% below previous level of functioning

Group 3: Vulnerability Group
Family history of psychosis in first degree relative OR Schizotypal Personality Disorder (as defined by DSM IV) in identified patient
Recency: Change in functioning occurred within last year
Impact: SOFAS score currently and for the last month a at least 30% below previous level of functioning
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subje

Exclusion Criteria

Exclusion criteria include:
i. Past history of a treated or untreated psychotic episode of one week’s duration or
longer
ii. Organic brain disease, e.g. epilepsy, inflammatory brain disease
iii. Abnormal coagulation profile parameters or thyroid function test results >10% above or below the limits of the normal range.
iv. Any physical illness with psychotropic effect, if not stabilized
v. Current treatment with lithium, methyl phenidate or ketamine, or recreational use of
ketamine.
vi. Past neuroleptic exposure equivalent to a total lifetime haloperidol dose of >50 mg.
[Refer to Appendix IV of the protocol for a list of equivalent doses for other neuroleptic agents.]
vii. Diagnosis of a serious developmental disorder, e.g. Asperger's syndrome
viii. Premorbid IQ < 70 and a documented history of developmental delay or intellectual
disability
ix. Current aggression/dangerous behaviour (CAARMS 5.4 severity score 6)
x. Current suicidality/self harm (CAARMS 7.3 severity score 6)
xi. Current pregnancy
xii. Current attenuated symptoms that are entirely explained by acute intoxication (e.g., current attenuated symptoms entirely explained by LSD use).
xiii. > than 4 weeks of regular omega-3 supplementation (>2 capsules standard strength providing >600 mg combined EPA/DHA) within the last 6 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified