Observational study on schizophrenia and psychotic disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Carl M Sellgren, MD, PhD
• Email: carl.sellgren@ki.se
• Phone: +46 702127287

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.