NCT06872463

Karolinska Schizophrenia Project

Brain Immunoactivation in Drug-Naive Patients with First Episode Schizophrenia

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Timeline

• Start date: 2011-01-25
• Primary completion: 2027-12-31
• Completion: 2032-12-31
• First posted: 2025-03-12
• Last updated: 2025-03-12

Locations

1 site across 1 country: Sweden