Primary objective of the current study is to develop and validate a prediction tool focusing on illness course and outcome at an individual level after patients have experienced a first episode of 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 Positive and Negative Syndrome Scale (PANSS),
Clinical Global Impression Scale (CGI), 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.
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 both
the illness course and outcome vary greatly among patients. 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 the 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 first
episode of 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 course and outcome at an individual level after
patients have experienced a first episode of 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 four 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. Both MRI and
blood sampling are safe procedures, and standard procedures will be followed to
minimise any risks. Visits 2, 3 and 4 are 2 months, 6 months and 1 year after
inclusion in the study, respectively. During all these visits, psychopathology
and psychosocial functioning will be examined. Visits 3 and 4 additionally
include measures of health and social needs, drug use, and cognition. Visit 4
also entails a follow-up MRI session and blood sampling. Individuals younger
than eighteen years of age (*16) can be included in this study, as a first
episode of psychosis typically emerges in adolescence or young adulthood.
Potential individual benefits are those associated with the close monitoring
and extensive examination of patients. 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.
Heidelberglaan 100 100
Utrecht 3584 CX
NL
Heidelberglaan 100 100
Utrecht 3584 CX
NL
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 regualtions.
*First episode of psychosis as defined by a DSM-IV diagnosis of schizophrenia or schizophreniform disorder or schizoaffective disorder (depressive type) on the basis of the Structured Clinical Interview for DSM-IV (SCID-I) (First et al., 2002).
Exclusion criteria
*A time interval between the onset of psychosis and study entry exceeding three years. Onset of psychosis is defined as the first contact with a healthcare professional during which the diagnosis *psychotic disorder* is set.
*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 their blood drawn and/or their MRI performed
*Incompetency to fully comprehend the purpose of the study or to make a rational decision whether or not to participate
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 | NL53930.041.15 |