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NCT05763966Recruiting

Uppsala Psychosis Cohort

Uppsala Psychosis Cohort: a Multimodal Study in Early Stage Psychosis Patients, High Risk Individuals and Healthy Controls

Source: ClinicalTrials.gov · Last updated 20 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

A multimodal longitudinal study in early stage psychosis patients and individuals at high risk for psychosis. Healthy controls are included for baseline comparisons. The aim is to investigate disease mechanisms of psychotic disorders, specifically focusing on the synaptic pruning hypothesis.

Status (registry)
Recruiting
Study type
Observational
Enrollment
120 (estimated)
First submitted
28 Feb 2023
Start date
1 Apr 2023
Primary completion date
31 Dec 2026
Lead sponsor
Uppsala University
NCT number
NCT05763966

What you commit to

  • Study type: Observational
  • Planned participants: 120
  • From 1 Apr 2023 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Exposure to an effective radiation dose of 25 mSv during the past year.
  • 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.

Other illness

  • Other dominant psychiatric illness that is deemed to be related to current psychotic symptoms (including bipolar disorder, major depressive disorder, autism)
  • A history of diagnosis of a major psychiatric disorder, including substance use disorders.
  • A family history of psychotic disorders or bipolar disorder in first degree relatives.
    • For all participants:
  • Meets diagnostic criteria of substance use disorder (excluding nicotine dependence) as assessed using DSM-5 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.

Lab values

  • 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.
  • 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

  • For EPP and CHR-P:
  • Long-term daily treatment (\<2 weeks) with benzodiazepines, such that there is an inability to refrain from treatment during testing procedures.
    • For HC:
  • Pregnancy, lactating or breastfeeding (women).
  • Lack of proficiency in Swedish language, or documented intellectual disability that prohibits ability to give informed consent.
  • 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.

Who the study is looking for

  • For EPP:
  • Diagnosis as assessed using DSM-5 of one of the following: schizophrenia, schizophreniform psychosis, psychosis not otherwise specified (NOS), brief psychosis, schizoaffective syndrome, delusional disorder
  • Onset of psychotic symptoms together with functional decline no more than 3 years prior to inclusion visit
    • For CHR-P:
    • Clinical high risk for psychosis as determined using Structured Interview for Psychosis-risk Syndromes (SIPS).

Age in the registry: 18 years to 40 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Uppsala University Hospital
Coordinator of this site? Confirm its status
UppsalaSwedenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.