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The NEURAPRO-E Study: A multicenter RCT of Omega-3 Fatty Acids and Cognitive-Behavioural Case Management for Symptomatic Patients at Ultra-High Risk for Early Progression to Schizophrenia and Other Psychotic Disorders

The NEURAPRO-E Study: A multicenter RCT of Omega-3 Fatty Acids and Cognitive-Behavioural Case Management for Symptomatic Patients at Ultra-High Risk for Early Progression to Schizophrenia and Other Psychotic Disorders - NEURAPRO-E

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39984
Enrollment
20
Registered
2012-08-22
Start date
2012-10-10
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

symptomatische patiënten met een verhoogd risico op een eerste psychose psychosis ultra high risk for developing psychosis

Interventions

Condition 1: fishoil and cognitive behavioural therapy plus casemanagement Condition 2: placebo and cognitive behavioural therapy plus casemanagement

Sponsors

Orygen Youth Health Research Centre
Lead Sponsor

Eligibility

Age
12 Years to 99 Years

Inclusion criteria

Inclusion criteria: A. General inclusion criteria: i. Ability to give informed consent Where participants are of legal childhood age, consent will also be obtained from one of the participant*s parents. Both the parent and participant will be required to sign the consent form in such a case. It will be the investigator*s responsibility to determine whether a participant of legal childhood age has the capacity to consent to the study. ii. Age 13 - 40 yrs B. Membership of one of the following *at-risk* groups: i. Vulnerability (Trait and State Risk Factor) Group: Individuals with a combination of a trait risk factor (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 or sustained low functioning during the past year. ii. Attenuated Psychotic Symptoms (APS) Group: 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 or sustained low functioning. iii. 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 or sustained low functioning.

Exclusion criteria

Exclusion criteria: 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 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

MeasureTime frame
Transition to psychosis

Secondary

MeasureTime frame
Severity of symptoms Level of functioning

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)