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.
Conditions
Interventions
Trade Name: EPAX 6000 TG
Product Name: Omega-3 fatty acids (EPA, DHA)
Pharmaceutical Form: Capsule, soft
CAS Number: 8000055007
Other descriptive name: OMEGA-3 MARINE TRIGLYCERIDES
Concentration unit:
Sponsors
Orygen Research Centre
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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 than 4 weeks of regular omega-3 supplementation (>2 capsules standard strength providing >600 mg combined EPA/DHA) within the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1) Are in addition to standard “state-of-the-art” treatment, omega-3 fatty acids EPA/DHA significantly more effective than placebo in reducing the rate of transition to a first episode of psychosis in an ‘at-risk’ cohort over a 12-month period? 2) Does the use of EPA/DHA result in a higher percentage of responders (i.e., symptomatic and functional improvement) compared to placebo? ;Secondary Objective: Are to determine: 1) If any clinical or demographic risk factors predict response to EPA/DHA treatment in the ‘at-risk’ group? 2) If lipid metabolism characteristics which have been observed in people with schizophrenia (e.g., reduced AA, increased iPLA2 activity) significantly more prevalent in those individuals who make a transition to psychosis? 3) If pre/post intervention changes in red blood cell fatty acids related to symptomatic and/or functional improvement? 4) If the use of EPA/DHA significantly improve cognitive functions (frontal cortex: executive function, attention; hippocampus: working memory) compared to placebo? ;Primary end point(s): Primary end point is a transition to a first episode of psychosis. Transition is operationally defined via rating scales, as in previous studies, as one of: 1. Abnormal thoughts held with delusional intensity occurring every day for one week or longer 2. True hallucinations in any modality occurring every day for one week or longer 3. Formal thought disorder to the degree of incoherence and/or loose associations occurring every day for one week or longer | — |
Countries
Austria
Outcome results
None listed