Main objectives: (1) To identify genetic, environmental and clinical determinants of psychosis vulnerability and onset. (2) To assess neural systems and behavioural substrates mediating gene environment interactions. (3) To test for gene-…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Patients with psychotic disorders such as schizophrenia, usually experience
early signs of psychosis for 1*5 years prior to the first episode of frank
illness. This early state is known as at risk mental state (ARMS) or prodrome.
Individuals with ARMS appear to be at extremely high risk of developing
psychosis* about one-third will do so, while two-thirds will not make a
transition to psychosis and their at-risk symptoms will either stay the same or
improve. It is unclear why only a subset of those who are highly vulnerable to
psychosis go on to develop the illness. There is increasing evidence that
aetiological models of schizophrenia need to incorporate the role of genetic,
social, psychological and biological factors, and to clarify how they interact.
In this study, state-of-the-art methods will be used to examine the genetic,
psychological and physiological interactions in individuals at high risk of
psychosis. The ultimate aim of this work-package is to deliver a tool that can
be used to help identifying genetic and environmental factors that, when they
interact, predict who is more likely to develop schizophrenia.
Study objective
Main objectives: (1) To identify genetic, environmental and clinical
determinants of psychosis vulnerability and onset. (2) To assess neural systems
and behavioural substrates mediating gene environment interactions. (3) To test
for gene-environment
interactions, as well as gene-gene and environment-environment interactions
playing a role in psychosis vulnerability and onset. (4) To develop
translational tools for the early prediction, diagnosis and course of
psychosis. Secondary objective: To disseminate the results to a critical mass
of stakeholders for policy counselling, integrating the expertise and views of
the European Commission and all relevant stakeholders groups to develop policy
recommendations and guidelines.
Study design
Over a five-year period, we will prospectively study young people experiencing
prodromal symptoms of schizophrenia in a naturalistic design.
The cohort of people with prodromal symptoms (n=400) will be collected by an
established network of European centres (EARN* European At Risk Network) in
London, Cambridge, Cologne, Munich, Amsterdam, Basel and Vienna. An additional
site (ORYGEN, Melbourne) that also meets the inclusion criteria has applied to
the Australian NHMRC for linked funding to participate in the proposal, as part
of the NHMRC-EU collaborative grant scheme. Inclusion of this site, one of the
largest clinical centres for the ARMS, does not incur costs to the EU. The
subjects presenting to these sites are young adults with an ARMS who are
seeking clinical help.
New patients are seen for the baseline clinical assessment, neuropsychological
clinical assessment and MRI when they are accepted into the service. If the
client agrees to take part to the research project, the information collected
during the assessment will be anonymised and used for the study. Also a blood
sample will be collected for DNA analysis.
We expect each participant to be in the study for 24 months. Participants will
be assessed at baseline, a 12 months and after 24 months after baseline (or
earlier if they make a transition to psychosis). Blood samples will only be
collected at baseline.
In the Netherlands, all assessments will take place at Academic Medical Center,
Amsterdam and at Parnassia, Den Haag.
Study burden and risks
Burden: All participants will be assessed using a number of clinical
scales/interviews and neuropsychological tests. A potential hazard of clinical
and cognitive assessment is that participants may experience anxiety and
emotional distress related to their performance. In addition, 25 ml blood will
be drawn for DNA and Serum purposes. No risks are attached to this study.
Meibergdreef 5
1105 AZ, Amsterdam
NL
Meibergdreef 5
1105 AZ, Amsterdam
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32721.018.10 |