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European Network of National Schizophrenia Networks Studying Gene-Environment interactions (EU-GEI). Work package 5: GenexEnvironment in the Prodrome

European Network of National Schizophrenia Networks Studying Gene-Environment interactions (EU-GEI). Work package 5: GenexEnvironment in the Prodrome - Identifying genetic and environmental interactions in psychosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON34336
Enrollment
45
Registered
2010-10-04
Start date
2010-07-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

At Risk Mental State Psychosis

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
12 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age 16 to 35 2. Adequate command of the Dutch language to complete the assessment 3. Meeting the criteria for an at risk mental state for psychosis as defined by the Personal Assessment and Crisis Evaluation Clinic (PACE) criteria (Yung et al 1998; Yung et al 2003). An individual meets criteria for the *at risk* mental state if they exhibit one or more of the following: 1) a schizotypal personality disorder or a first degree relative with psychosis plus a recent decline in function* 2) *attenuated* positive psychotic symptoms, like ideas of reference, odd beliefs, magical thinking, or unusual perceptual experiences* and 3) a brief psychotic episode of less than one week duration that resolves without antipsychotic medication.

Exclusion criteria

Exclusion criteria: - Having had a psychotic episode for more than one week - Symptoms relevant for inclusion are explained by a medical disorder or drugs or alcohol dependency - IQ

Design outcomes

Primary

MeasureTime frame
The main outcome measure is transition status to first- episode psychosis within 24months post study entry. Transition is operationally defined via rating scales, 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

Secondary

MeasureTime frame
1. We will examine exposure to the main environmental factors implicated in psychosis: childhood urbanicity and trauma, ethnicity, adolescent cannabis use, acute stress, social discrimination and social defeat. 2. Level of symptomatology, including depression, positive, negative, and basic symptoms 3. Level of functioning across a range of domains including peer relations, family functioning, vocational, and occupational functioning. The following secondary outcome cut points will be applied: Remission will be defined as at least a 50% reduction in the CAARMS positive symptoms score. Recovery will be defined as at least a 50% reduction in key symptom measures (as above) plus improvement in functioning to premorbid level.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)