Health TrialsbyHealthPanel

Karolinska Schizophrenia Project

ConditionSchizophrenia and Disorders with Psychotic Features
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this trial

KaSP is a multimodal observational study with the goal of clarifying underlying mechanisms that cause psychotic disorders, such as schizophrenia. Participants with psychotic symptoms are recruited early after first contact with health care, within 4 weeks of starting anti-psychotic medication, and are compared to controls without psychiatric diagnoses on several measures.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosis as assessed using DSM-IV of one of the following: schizophrenia, schizophreniform psychosis, psychosis not otherwise specified (NOS), brief psychosis, schizoaffective syndrome, delusional disorder

First exposure to anti-psychotic medication less than 4 weeks prior to inclusion

Disqualifiers

A history of diagnosis of a major psychiatric disorder, including substance use disorders.

Family history of psychotic disorders in first degree relatives.

Evidence based on medical history, clinical signs, MRI or laboratory tests of clinically significant somatic disorder, or previous disorder with brain engagement (e.g. tumour, neuroinflammatory disease, epilepsy) or significant brain trauma.

Exposure to an effective radiation dose of 25 mSv during the past year.

Trial population

FEP are recruited from psychiatry clinics in the greater Stockholm area. HC are recruited by advertisement.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: First Episode Psychosis (FEP)
Group B: Healthy Control (HC)

Trial outcomes

Primary outcomes

1

Kynurenic acid (KYNA) in FEP compared to HC

KYNA are measured in CSF and blood samples

Time frame
Baseline measure
2

Cytokines in FEP compared to HC

Cytokines are measured in CSF and blood samples

Time frame
Baseline measure
3

Microglial activation in FEP compared to HC

Group comparison of binding of the PET ligand \[11C\]PBR-28

Time frame
Baseline measure
4

Dopamine receptors in FEP compared to HC

Group comparison of binding of the PET-ligand \[11C\]FLB457

Time frame
Baseline measure

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Region Stockholm

Collaborator

Source ClinicalTrials.gov
Apply now