Cohort of patients with schizophrenia and those at risk of developing it
The Danish Region Midt Schizophrenia (RMS) Cohort: Representative Cohort of Patients With a First-episode Schizophrenia Spectrum Disorder With Long-term Follow-up
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 |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 5 sites (Aarhus and 4 other locations) |
| Trial ID | NCT06431009 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients currently under coercive measures or those deemed unable to participate by their clinician will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aarhus and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.