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

Conditions: At Risk Mental State
Psychosis
10039628

Registration Number: NL-OMON34336

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 45

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

- 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 <60

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome measure is transition status to first- episode psychosis<br /><br>within 24months<br /><br>post study entry. Transition is operationally defined via rating scales, as one<br /><br>of:<br /><br>1. Abnormal thoughts held with delusional intensity occurring every day for one<br /><br>week or longer<br /><br>2. True hallucinations in any modality occurring every day for one week or<br /><br>longer<br /><br>3. Formal thought disorder to the degree of incoherence and/or loose<br /><br>associations occurring every day for one week or longer</p><br>

Secondary Outcome Measures

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