Cohort of patients with schizophrenia and those at risk of developing it
Official title: The Danish Region Midt Schizophrenia (RMS) Cohort: Representative Cohort of Patients With a First-episode Schizophrenia Spectrum Disorder With Long-term Follow-up
Run by University of Aarhus · NCT06431009 · Data updated 2026-11-12
This study is looking at how childhood experiences and the immune system might affect people with schizophrenia and those at high risk of developing it over two years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 15 Years and up |
| Sex | All |
| Enrollment | 350 (estimated) |
| Sponsor | University of Aarhus Academic / other |
| Locations | 5 sites (Aarhus and 4 other locations) |
| Status | Recruiting |
| Started | February 20, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 29, 2024 |
| Trial ID | NCT06431009 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 15 years and older who have been diagnosed with a first-episode SSD or are identified as UHR within the last three months.
✕Probably not a fit
Patients currently under coercive measures or those deemed unable to participate by their clinician will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational cohort study aims to recruit patients diagnosed with schizophrenia spectrum disorders (SSD) and ultra-high risk (UHR) individuals within three months of their first diagnosis. The study will follow these patients over a period of two years, with planned visits and online questionnaires to gather data on their experiences and health outcomes. The primary focus is to investigate the role of adverse childhood experiences and the immune system in the development and progression of schizophrenia. The study will take place across multiple psychiatric hospitals in the Central Denmark Region.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the factors influencing schizophrenia, potentially leading to improved prevention and treatment strategies.
How similar studies have gone: While similar cohort studies have been conducted, this specific focus on the interplay of adverse childhood experiences and the immune system in schizophrenia is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥15 years 2. Diagnosed within the previous 3 months with first-episode SSD (ICD-10: F20-29) or UHR (ICD-10: F1X.5) 3. Able to give informed oral and written consent. Exclusion Criteria: 1. Any coercive measure including patients in forensic psychiatry 2. In a clinical condition where the treating clinician evaluates that the patient is not able to attend the research study.
Where it's running
-
Aarhus University Hospital Psychiatry
Aarhus, Denmark Recruiting -
Psychiatric Hospital Gødstrup
Herning, Denmark Recruiting -
Psychiatric Hospital Horsens
Horsens, Denmark Recruiting -
Psychiatric Hospital Randers
Randers, Denmark Recruiting -
Psychiatric Hospital Midt
Silkeborg, Denmark Recruiting
Study contacts
- Study coordinator: Ole Köhler-Forsberg, MD, PhD
- Email: karkoe@rm.dk
- Phone: 0045 78471610
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.