Karolinska Schizophrenia Project

Recruiting now

Conditions studied: Schizophrenia and Disorders with Psychotic Features

In brief

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.

Key facts

Study ID

NCT06872463

Run by

Karolinska Institutet

People needed

200

Starts

2011-01-25

Expected to finish

2032-12-31

Last updated by the study team

2025-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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

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.
• 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 is running

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

Full record on ClinicalTrials.gov

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