Karolinska Schizophrenia Project

NCT ID: NCT06872463

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-25
• Study Completion Date: 2032-12-31

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.

Detailed Description

KaSP aims to recruit 120 patients sparsely medicated or drug-naive first episode psychosis (FEP) individuals, along with 80 healthy controls.

Participants undergo the following assessments and measurements:

• Clinical assessment
• Cognitive testing
• Lab results from cerebrospinal fluid, blood, urine, saliva and skin biopsy
• Brain imaging using Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET)
• Pre-Pulse Inhibition (PPI) (a test to evaluate the startle response)
• Measures of arterial stiffness and amount of vascular narrowing

Participants with psychosis are invited back for repeat measurements at 1,5 and 5 years after study enrollment. Controls may be invited back at 1,5 years for repeat of some of the assessments.

Conditions

Schizophrenia and Disorders with Psychotic Features

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Healthy Control (HC)

Age and sex matched individuals

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.
• Symptoms of severe bacterial, fungal, or viral infection (including upper respiratory tract infection), with systemic effects as detected by e.g. fever, within 7 days prior to inclusion.
• Treatment with any antihemostatic medication within 2 weeks of lumbar puncture and arterial line placement of either the baseline or 1 year follow-up.
• Blood donation (1 unit or more) within 90 days prior to Screening, plasma donation from 1 week prior to Screening, and platelet donation from 6 weeks prior to inclusion.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre for Psychiatry Research, Region Stockholm, Sweden

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Carl Sellgren

Associate Professor Carl Sellgren Majkowitz

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

SLSO Psykiatri Stockholm in collaboration w Karolinska Institutet

Stockholm, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Carl M Sellgren, MD, PhD

Role: CONTACT

carl.sellgren@ki.se

+46 702127287

Lena Lundberg

Role: CONTACT

lena.lundberg.2@ki.se

+46725223907

Facility Contacts

Carl M Sellgren, MD, PhD

Role: primary

carl.sellgren@ki.se

0046702127287

Related Links

https://ki.se/en/research/research-areas-centres-and-networks/research-groups/applied-developmental-neurobiology-carl-sellgren-research-group#tab-the-karolinska-schizophrenia-project-kasp-

Related Info

Other Identifiers

2010/879-31/1

Identifier Type: -

Identifier Source: org_study_id