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Hersenvocht bij psychiatrische aandoeningen

The relevance of cerebrospinal fluid to neurobehavioral traits

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26758
Enrollment
800
Registered
2016-07-29
Start date
2017-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Psychosis, schizophrenia, affective disorders, depression

Interventions

Obtain CSF and questionnaires and blood

Sponsors

University Medical Center Utrecht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Psychotic disorder patients: a DSM-IV or 5 classification of schizophrenia, schizophreniform disorder, schizoaffective disorder (both depressive and bipolar types), psychosis not otherwise specified (or other unspecified psychotic disorders), major depressive disorder with psychotic features, bipolar disorder with current psychotic features or a history of psychotic features and psychosis during the peripartum period (8 weeks after giving birth). DSM-IV or DSM-5 diagnosis will be clinician-rated or based on semi-structured interviews (i.e. the Semi-structured Clinician Interview for DSM Disorders, SCID). Affective disorder patients: a DSM-IV or 5 classification of unipolar depressive or bipolar disorders without psychotic features. DSM-IV or DSM-5 diagnosis will be clinician-rated or based on semi-structured interviews (i.e. the Semi-structured Clinician Interview for DSM Disorders, SCID). Healthy controls: participants in our previous study who consented to be contacted for future research purposes will be asked to fill out the one questionnaire that was not used in the previous study, the Youth Trauma Questionnaire (listed below). New healthy controls will be asked to fill out all questionnaires. All participants: age > 18 years.

Exclusion criteria

Exclusion criteria: Patients with psychotic or affective disorders Subjects meeting any of the following criteria will be excluded from participation in this study: -Lumbar-puncture specific (relative) contra-indications, again abiding by the UMCU protocol for LPs (see ‘C1_Addendum_bij_Onderzoeksprotocol_Werkdocument Lumbaal punctie_herzien april 2015.pdf’): a history of a severe adverse reaction to a previous lumbar puncture (reported by the subject and/or evident from the medical record, including post-puncture headache), the use of anticoagulant agents, thrombocytopenia, local infection of the skin, clinical signs of raised intracranial pressure or a suspected spinal epidural abscess. - Although clotting abnormalities and suspected bacteraemia do not constitute contraindications for LPs, patients suffering from these will be excluded to avoid risks of excessive bleeding and infections. - Patients who are not mentally competent and who don't have decisional capacity to decide about participation in this study will not be included. Doctors assess mental competence and decisional capacity of patients to ascertain whether they are able to express a choice, understand and appreciate the information provided and reason about their possible participation. If there is any doubt about their mental competency or decisional capacity, the patient will not be included. - Patients who were admitted to a psychiatric unit involuntarily after being given an ‘inbewaringstelling’ (IBS) will not be included. Patients with ‘rechterlijke machtigingen’ (RM) may be included, but only if they are mentally competent (see section on mental competence and decisional capacity above). The reasons for including the latter category of patients is that the inclusion of these patients will contribute to assembling a study population representative of all Dutch psychotic disorder patients. - Some patients may participate in other studies as well. In those instances, the researchers of both studies discuss the option of simultaneous enrollment and decide about inclusion of the patient. Any decision about participation of patients in two studies will be based on balancing the advantages of dual study participation with the burden of such participation for participants. Healthy controls Subjects meeting any of the following criteria will be excluded from participation in this study: - A current or past history of self-reported major psychiatric or neurological illness. - Lumbar-puncture specific (relative) contra-indications: the anesthesiologist assesses these during routine pre-operative screening.

Design outcomes

Primary

MeasureTime frame
CSF constituents: -Autoantibodies to CNS receptors. -A panel of cytokine, chemokine and growth factor levels. -MiRNA levels. -Neurotransmitter concentrations (including GABA, glutamate and all major amino acids). - Plasma: Plasma levels of the CSF constituents mentioned under primary parameters. - Genetic assessments: To unravel the contribution of genetic variation to the quantitative phenotypes under investigation here, and thereby potentially aid in the identification of genetic variation underlying psychosis, a hypothesis-driven genetic approach will be adopted. -To link biochemical and genetic data to the behavioral level, we will have participants fill out questionnaires assessing a range of behavioral traits, as mentioned below.

Secondary

MeasureTime frame
- Plasma: Plasma levels of the CSF constituents mentioned under primary parameters. - Genetic assessments: To unravel the contribution of genetic variation to the quantitative phenotypes under investigation here, and thereby potentially aid in the identification of genetic variation underlying psychosis, a hypothesis-driven genetic approach will be adopted. -To link biochemical and genetic data to the behavioral level, we will have participants fill out questionnaires assessing a range of behavioral traits, as mentioned below.

Contacts

Public ContactJurjen Luykx
Jluykx@umcutrecht.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)