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Prediction of illness course and outcome in patients with a first episode of psychosis

Prediction of illness course and outcome in patients with a first episode of psychosis - Prediction of prognosis after a first psychotic episode

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47512
Enrollment
86
Registered
2016-03-30
Start date
2016-10-24
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

first episode of psychosis

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

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 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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime 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

Source: NL-OMON (via WHO ICTRP)