Cerebrospinal Fluid and Psychiatric Disorders (CSFPsych) - Cerebrospinal Fluid and Psychiatric Disorders

niversitair Medisch Centrum Utrecht0 sites500 target enrollmentTBD

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: niversitair Medisch Centrum Utrecht
Enrollment: 500
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

2 years ago

Study Type

Observational invasive

Investigators

Sponsor

niversitair Medisch Centrum Utrecht

Eligibility Criteria

Inclusion Criteria

•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 and without psychotic features), bipolar disorder (with and without current psychotic features or a history of psychotic features) and psychosis during the peripartum period (8 weeks after giving birth).

Exclusion Criteria

•Patients with a psychotic or affective disorder:
•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.