Karolinska Schizophrenia Project

NCT06872463 | Recruiting

• 1 other identifier: 2010/879-31/1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia and Disorders with Psychotic Features

Keywords

Psychosis; Psychotic disorders; Schizophrenia

Outcome Measures

Primary Outcomes (5)

• Kynurenic acid (KYNA) in FEP compared to HC

  KYNA are measured in CSF and blood samples

  Baseline measure

• Cytokines in FEP compared to HC

  Cytokines are measured in CSF and blood samples

  Baseline measure

• Microglial activation in FEP compared to HC

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

  Baseline measure

• Dopamine receptors in FEP compared to HC

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

  Baseline measure

• Infectious risk factors in FEP and subsequent relation to clinical outcome

  Registry data on previous infections, along with infectious agents measured in CSF and blood. Long term clinical outcome is measured through registry data, by drug-dispensation as well as in-and outpatient care for both somatic and psychiatric disorders.

  Registry data in childhood, measurement at baseline, registry data through study completion (with an expected average of 7 years of follow up)

Study Arms (2)

First Episode Psychosis (FEP)

Diagnosis of psychotic disorder according to the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV), where anti-psychotic medication was initiated less than four weeks prior to inclusion.

Healthy Control (HC)

Age and sex matched individuals

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• For FEP:
• 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

You may not qualify if:

• For FEP:
• \- Other dominant psychiatric illness deemed to be related to current psychotic symptoms
• For HC:
• A history of diagnosis of a major psychiatric disorder, including substance use disorders.
• Family history of psychotic disorders in first degree relatives.
• For all:
• 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.
• Pregnancy, lactating or breastfeeding (women).
• Meets diagnostic criteria of substance use disorder (excluding nicotine dependence) as assessed using DSM-IV or as determined using repeated positive urine screens during the course of the study.
• Metallic object in the eye, or ferro/electromagnetic implants. History of claustrophobic anxiety during MRI.
• Treatment with any antihemostatic medication within 2 weeks of lumbar puncture and arterial line placement of either the baseline or 1 year follow-up.
• Other unspecified reasons that, in the opinion of the Investigator or the Sponsor, make the participant unsuitable for enrollment. This may include very high symptom severity or signs of aggressiveness and hostility.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Centre for Psychiatry Research, Region Stockholm, Sweden: collaborator

Study Sites (1)

SLSO Psykiatri Stockholm in collaboration w Karolinska Institutet

Stockholm, Sweden

RECRUITING

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal fluid (CSF), whole blood, fibroblasts

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Carl M Sellgren, MD, PhD

CONTACT

+46 702127287; carl.sellgren@ki.se

Lena Lundberg

CONTACT

+46725223907; lena.lundberg.2@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Carl Sellgren Majkowitz

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 12, 2025
• Study Start: January 25, 2011
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

SE (1)