Karolinska Schizophrenia Project

Last updated: March 10, 2025
Sponsor: Karolinska Institutet
Overall Status: Active - Recruiting

Phase

N/A

Condition

Schizotypal Personality Disorder (Spd)

Autism

Tourette's Syndrome

Treatment

N/A

Clinical Study ID

NCT06872463
2010/879-31/1
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

For FEP:

  • Diagnosis as assessed using DSM-IV of one of the following: schizophrenia,schizophreniform psychosis, psychosis not otherwise specified (NOS), briefpsychosis, schizoaffective syndrome, delusional disorder

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

Exclusion

Exclusion Criteria:

For FEP:

  • Other dominant psychiatric illness deemed to be related to current psychoticsymptoms

For HC:

  • A history of diagnosis of a major psychiatric disorder, including substance usedisorders.

  • Family history of psychotic disorders in first degree relatives.

For all:

  • Evidence based on medical history, clinical signs, MRI or laboratory tests ofclinically 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 screensduring the course of the study.

  • Metallic object in the eye, or ferro/electromagnetic implants. History ofclaustrophobic anxiety during MRI.

  • Symptoms of severe bacterial, fungal, or viral infection (including upperrespiratory 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 andarterial line placement of either the baseline or 1 year follow-up.

  • Blood donation (1 unit or more) within 90 days prior to Screening, plasma donationfrom 1 week prior to Screening, and platelet donation from 6 weeks prior toinclusion.

  • Other unspecified reasons that, in the opinion of the Investigator or the Sponsor,make the participant unsuitable for enrollment. This may include very high symptomseverity or signs of aggressiveness and hostility.

Study Design

Total Participants: 200
Study Start date:
January 25, 2011
Estimated Completion Date:
December 31, 2032

Study 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.

Connect with a study center

  • SLSO Psykiatri Stockholm in collaboration w Karolinska Institutet

    Stockholm,
    Sweden

    Active - Recruiting

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