Primary objective of the current study is to develop and validate a prediction tool focusing on illness onset, course and outcome at an individual level in individuals at high risk for developing psychosis. This will be achieved by combining the…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Psychopathology will repeatedly be examined using semi-structured interviews
and questionnaires including the Comprehensive Assessment of At-Risk Mental
States (CAARMS), Hamilton Depression Rating Scale (HAM-D), Young Mania Rating
Scale (YMRS). Psychosocial function is assessed with the Global Assessment of
Functioning scale (GAF). The PANSS will also be used to assess illness severity
and symptomatic remission. Brain structure and function are measured in two
Magnetic Resonance Imaging (MRI) sessions, consisting of structural MRI,
resting state functional MRI and Diffusion Tensor Imaging (DTI). Cognition will
be assessed using a computerised battery of neuropsychological tests that
capture key deficits associated with psychosis, such as attention, memory,
emotion recognition and executive function. Blood samples will be drawn to
assess levels of genetic, proteomic, metabolomic and immune parameters. One
hair sample will be taken for keratinocyte biomarker analyses. EEG measurements
will be done, but this is optional for the participant.
Secondary outcome
Other study parameters include sociodemographics, medical history, physical
health, current medication use, recent psychiatric history, psychiatric
disorders in first-degree relatives, hospitalisations, and use of drugs of
abuse. Handedness (Edinburgh Handedness Inventory), childhood maltreatment
(Childhood Trauma Questionnaire) and resilience (Resilience Scale for Adults)
will be assessed with self-report questionnaires. Premorbid function is
determined using the Premorbid Adjustment Scale (PAS), health and social needs
are assessed with the Camberwell Assessment of Need Short Appraisal Schedule
(CANSAS-P) and IQ is assessed using the Wechsler's Adult Intelligence Scale
(WAIS).
Current and past episodes of psychopathology will be determined using the
Structured Clinical Interview for DSM Disorders (SCID).
Background summary
Psychotic disorders are relatively common and severely disabling, although
illness onset, course and outcome vary greatly among patients. Not all people
with a high risk of developing psychosis will develop the disease. In addition,
following a first episode of acute psychosis, some patients make a good
recovery, whereas others have series of relapses and remissions, or have an
unremitting course of the illness. To date, however, we are not able to
reliably predict onset, course and outcome of psychosis at an individual level.
As such, there is a pressing need to assist clinical decision-making by
developing objective methods to predict psychotic episodes and outcomes in
order to tailor psychiatric care to the needs of each patient * i.e. to provide
personalised care. Through the current study, we aim to predict illness course
and outcome in patients with a very high risk of developing psychosis on the
basis of measures of psychopathology, brain structure and function, cognition,
and biological markers in blood. These data will be used to develop and
validate a quantitative and objective tool that will enable healthcare
professionals to tailor psychiatric care to the particular needs of each
patient.
Study objective
Primary objective of the current study is to develop and validate a prediction
tool focusing on illness onset, course and outcome at an individual level in
individuals at high risk for developing psychosis. This will be achieved by
combining the predictive values of measures of psychopathology, clinical
characteristics, brain structure and function, cognition, psychosocial
functioning and biological markers in blood.
Study design
An international, multicentre, naturalistic follow-up study.
Study burden and risks
This study includes seven visits (see for details Table 1 of the protocol).
Visit 1 consists of collection of demographic and medical information,
assessment of IQ, handedness, childhood trauma, resilience and premorbid
function, and administration of a diagnostic interview. In addition, baseline
examination of psychopathology, psychosocial functioning, health and social
needs, drug use, and cognition is performed, and subjects will undergo a
baseline MRI session of at maximum sixty minutes. A blood sample is drawn to
assess genetic, proteomic, metabolomic and immune parameters. An EEG will be
made, but this is optional for the participant. Both MRI and blood sampling are
safe procedures, and standard procedures will be followed to minimise any
risks. Participants will be asked to come back after 3 months (visit 2), 6
months (visit 3), 12 months (visit 4), 18 months (visit 5) and 24 months (visit
6). The visits at 6 and 12 months (visit 3 and 4) will involve the same
assessments, EEG sampling, MRI scanning, and blood sample as visit 1, but
without some of the initial questions about things like age and medical history
and hair sampling. Assessments at 3,18 and 24 months (visit 2, 5 and 6) will
involve only questionnaires about recent experiences and things like
medication. The assessments of each visit can be completed in multiple days.
Individuals younger than eighteen years of age (*16) can be included in this
study, as the risk of developing psychosis typically emerges in adolescence or
young adulthood. Potential individual benefits are those associated with the
close monitoring and extensive examination of participants. Since the current
study entails a naturalistic design, and assessments (with the exception of
drawing blood) are essentially non-invasive, associated risks are deemed
negligible. Although there are a substantial number of assessments, it is
allowed to complete assessments of each visit in multiple days and participants
will be offered frequent breaks. Hence, the burden associated with
participation is deemed minimal.
De Crespigny Park, 16
London SE5 8AF
GB
De Crespigny Park, 16
London SE5 8AF
GB
Listed location countries
Age
Inclusion criteria
* 16-40 years old
* Written informed consent of subjects aged 18 to 40 years
* Written informed consent of parents and/or legal guardians for subjects aged
16 or 17, in
addition to assent from the minor subject, following local laws and regulations
Participants at high risk of psychosis will be evaluated using a quantitative
clinical tool that
assesses:
* Inclusion into one of three groups as assessed by the Comprehensive
Assessment of At-Risk Mental States (CAARMS version 2006):
i) vulnerability group,
ii) attenuated psychosis group,
iii) brief intermittent psychosis symptoms group.
Exclusion criteria
* Any previous neurosurgery or neurological disorder, including epilepsy
* History of head injury resulting in unconsciousness lasting at least 1 hour
* Pregnancy
* Any contraindications for MRI
* Refusing to have blood drawn and/or MRI performed
* Subject is unable to fully comprehend the purpose of the study or make a
rational
decision whether or not to participate
* Estimate of IQ < 70
* Antipsychotic medication for > 30 days (cumulative number of days) in the 3
months
before the baseline assessments (including self-ratings and screening
assessments), at
doses that would be adequate for treating a first episode of psychosis (i.e.
excludes very
low doses)
* Any past episode of frank psychosis lasting > 7 days
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 | NL55065.041.15 |