Studies brain changes in early psychosis, high-risk people and healthy controls

Trial details

Who runs it

Uppsala University

Trial code

NCT05763966

Record updated

20 February 2025

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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).

Exclusion: 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 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; 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; 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.

ClinicalTrials.gov NCT05763966