high risk of psychosis schizophrenia
Conditions
Interventions
None listed
Sponsors
Institute of Psychiatry, King's College, London
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
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
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 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Netherlands
Outcome results
None listed