The Danish Region Midt Schizophrenia Cohort

NCT06431009 | Recruiting DMC

• 1 other identifier: 2024-001
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 5

Brief Summary

The objective of this study is to recruit patients at the first diagnosis with a schizophrenia spectrum disorder (SSD) and ultra-high risk patients (UHR), defined as patients with drug abuse and psychotic symptoms indicating a risk for developing schizophrenia. Thereby, the investigators aim to establish a large representative cohort of patients with a first-episode SSD or patients at UHR, enabling investigations of the etiology and long-term prognosis of SSDs. The primary aim is to learn more about the importance of adverse childhood experiences (ACEs) and the immune system in the etiology and course of schizophrenia. Patients will be followed with planned visits after 1, 2, 3, 12 and 24 months including online questionnaires after 2, 6, 10 and 26 weeks. There will be the possibility to contact patients again for subsequent follow-up visits.

Conditions

Schizophrenia

Keywords

Schizophrenia; Antipsychotics; Adverse Childhood Experiences (ACE); Immune system

Outcome Measures

Primary Outcomes (1)

• Adverse childhood experiences (ACEs)

  The primary endpoint is the correlation between adverse childhood experiences (ACEs, from 0 to 13 ACEs measured via the World Health Organization (WHO) ACE-IQ), reported at baseline, with the change on the 6-item positive and negative symptom scale (PANSS-6, minimum score=0, maximum score=30), with higher PANSS-6 scores indicating greater symptom severity

  from baseline to follow-up visits after 52 and 104 weeks.

Secondary Outcomes (4)

• Cognition

  from baseline to follow-up visits after 52 and 104 weeks.

• Sleep

  from baseline to follow-up visits after 52 and 104 weeks.

• Quality-of-life

  from baseline to follow-up visits after 52 and 104 weeks.

• Level of functioning

  from baseline to follow-up visits after 52 and 104 weeks.

Study Arms (2)

Schizophrenia

Patients with a SSD (ICD-10: F20-29) aged ≥15 years.

Other: Treatment-as-usual

Ultra High Risk

Patients at UHR (ICD: 1\*.5) aged ≥15 years.

Other: Treatment-as-usual

Interventions

Treatment-as-usual OTHER

Patients will be treated and followed according to normal clinical treatment guidelines at the local psychiatric hospitals, which will not be affected by participation in the RMS cohort.

Schizophrenia; Ultra High Risk

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any patient aged ≥15 years diagnosed with first-episode SSD or UHR diagnosis and without any coercive measure at the time of inclusion will be relevant for inclusion in the study.

You may qualify if:

• Age ≥15 years
• Diagnosed within the previous 3 months with first-episode SSD (ICD-10: F20-29) or UHR (ICD-10: F1X.5)
• Able to give informed oral and written consent.

You may not qualify if:

• Any coercive measure including patients in forensic psychiatry
• In a clinical condition where the treating clinician evaluates that the patient is not able to attend the research study.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (5)

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

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Ole Köhler-Forsberg, MD, PhD

CONTACT

0045 78471610; karkoe@rm.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: May 28, 2024
• Study Start: February 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5)