Observational study on schizophrenia and psychotic disorders

Brain Immunoactivation in Drug-Naive Patients with First Episode Schizophrenia

This study is trying to understand the causes of schizophrenia and other psychotic disorders by looking at people having their first episode of psychosis and comparing them to healthy individuals over several years.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Karolinska Institutet (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Stockholm)
• Trial ID: NCT06872463 on ClinicalTrials.gov

What this trial studies

The Karolinska Schizophrenia Project (KaSP) is a multimodal observational study designed to investigate the underlying mechanisms of psychotic disorders, particularly schizophrenia. It aims to recruit 120 individuals experiencing their first episode of psychosis who are either sparsely medicated or drug-naive, alongside 80 healthy controls. Participants will undergo a variety of assessments, including clinical evaluations, cognitive testing, and advanced imaging techniques like MRI and PET. The study will also measure biological markers through cerebrospinal fluid, blood, and other samples, with follow-up assessments planned at 1, 5, and 10 years post-enrollment.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with their first episode of psychosis who have recently started anti-psychotic medication.

Not a fit: Patients with other dominant psychiatric illnesses or significant somatic disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of the mechanisms behind schizophrenia, potentially leading to improved treatment strategies.

How similar studies have performed: Other studies investigating the mechanisms of psychotic disorders have shown promise, but this specific approach is relatively novel.

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.

Where this trial is running

Stockholm

• SLSO Psykiatri Stockholm in collaboration w Karolinska Institutet — Stockholm, Sweden (Recruiting)

Study contacts

• Study coordinator: Carl M Sellgren, MD, PhD

Conditions Schizophrenia and Disorders with Psychotic Features; Psychosis; Psychotic disorders; Schizophrenia