The Danish Region Midt Schizophrenia Cohort

Schizophrenia Clinical Trial

— RMS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06431009
• Other study ID #: 2024-001
• Status: Recruiting
• Start date: February 20, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: University of Aarhus
• Contact: Ole Köhler-Forsberg, MD, PhD
• Phone: 0045 78471610
• Email: karkoe[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Study design: Cohort study with pre-defined longitudinal follow-up visits. Patients: Patients with a SSD (ICD-10: F20-29) or patients at UHR (ICD: 1*.5) aged ≥15 years.

Sample size: Within the Central Denmark Region (CDR), approximately 700 patients are each year diagnosed with a SSD and 100 with UHR. The investigators will establish recruitment at all psychiatric hospitals in the CDR between January 2024 until June 2025. Our aim is to establish continued recruitment of 100-150 patients/year. Hence, the investigators expect to recruit 300-350 patients during the period 2024-2026.

Procedures: Patients will be included within three months of the first SSD or UHR diagnosis at one of the psychiatric hospitals in the CDR. Before inclusion, an interview with the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) interview will validate the diagnosis. At baseline and follow-up visits (details in the full protocol and Table 1), patients will be rated by use of the 6-item Positive and Negative Syndrome Scale (PANSS-6), the Clinical Global Impression Severity Scale (CGI-S), the Global Assessment of Functioning Scale (GAF), the Schizophrenia Quality of Life Scale (SQLS), Alcohol Use Disorders Identification Test (AUDIT), Drug Use Disorders Identification Test (DUDIT), Fagerström Test for Nicotine Dependence (FTND), Major Depression Inventory (MDI), the Aarhus Side effect Assessment Questionnaire (ASAQ), the "Udvalg for Kliniske Undersøgelser" side effect scale (UKU), and the Calgary Depression Scale for Schizophrenia (CDSS). Furthermore, patients will fill out the self-reported WHO Adverse Childhood Experience International Questionnaire (ACE-IQ) and the Insomnia Severity Index (ISI), the Epsworth Sleepiness Scale (ESS), and the Pittsburgh Sleep Quality Index (PSQI) to measure sleep. The Matrics Consensus Cognitive Battery (MCCB), which consists of 10 cognitive tests, will measure cognition. To measure consciousness, patients will fill out the Perceived Stress Scale (PSS), Toronto Alexithymia Scale (TAS-20), and Metacognition Superiority illusion. During the first three months, participants will wear an actigraph to have a proxy measure of activity and sleep. Blood sampling will be performed at baseline and after 3, 12 and 24 months to measure markers of inflammation and to enable genetic and epigenetic analyses. Heart rate, blood pressure, height, body weight, waist and hip circumference will be recorded. Patients will be treated according to clinical indication, i.e., they will receive routine clinical care at the local psychiatric hospital and participation in this study will not affect the treatment. Patients can be included in this study independent of whether they are treated with psychotropic drugs or not.

Follow-up: 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. Patients will have follow-up visits for the RMS study after 1, 2, 3, 12 and 24 months after the individual inclusion date and fill out online questionnaires after 2, 6, 10, and 26 weeks.

Endpoints: The primary endpoint is the correlation between ACEs and inflammatory markers measured at baseline with the change on PANSS-6 from baseline to follow-up visits. Key secondary endpoints include changes in genetic, epigenetics, cognition, PSQI and ISI. Additional secondary endpoints include changes in ASAQ, UKU, SQLS, CDSS, GAF, CGI-S, body weight, hip and waist circumference, blood pressure, and heart rate. For patients enrolled in the study, all endpoints will initially be collected and several repeated during the study duration.

Safety: Patients will follow treatment-as-usual at their local hospital, with the clinicians from the local hospital being responsible for safety monitoring according to local treatment guidelines. Blood sample results will be obtained from the patient's medical record (MidtEPJ) at the study visits to monitor biochemical safety parameters for medical treatment. Between follow-up visits for the RMS cohort, patients will follow guideline-based safety monitoring at the local psychiatric hospital.

Study duration: Continuous. The investigators aim to establish continuous recruitment and that all patients with a first-episode SSD or UHR diagnosis fulfilling inclusion criteria will be offered participation in the RMS Cohort.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Treatment-as-usual
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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital Psychiatry	Aarhus
Denmark	Psychiatric Hospital Gødstrup	Herning
Denmark	Psychiatric Hospital Horsens	Horsens
Denmark	Psychiatric Hospital Randers	Randers
Denmark	Psychiatric Hospital Midt	Silkeborg

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cognition	Changes in cognition, measured via matrics consensus cognitive battery (MCCB, presenting T-scores (minimum=0, maximum=60) for 7 different cognitive domains) with higher scores indicating better cognitive functioning	from baseline to follow-up visits after 52 and 104 weeks.
Secondary	Sleep	Changes in sleep quality (measured via Pittsburgh Sleep Quality Index (PSQI, minimum score=0, maximum score=39) and Insomnia Severity Index (ISI, minimum score=0, maximum score=28), with both measures indicating worse sleep quality depending on higher scores on the scales)	from baseline to follow-up visits after 52 and 104 weeks.
Secondary	Quality-of-life	Changes in quality-of-life (measuring psychosocial quality-of-life, energy+motivation, and symptoms+side effects via the Schizophrenia Quality of Life Scale (SQLS, minimum score=0, maximum score=30), with higher scores indicating worse quality-of-life)	from baseline to follow-up visits after 52 and 104 weeks.
Secondary	Level of functioning	Changes in level of functioning, (measured via the Global Assessment of Functioning (GAF), with higher scores on a scale from 0 to 100 indicating better functioning)	from baseline to follow-up visits after 52 and 104 weeks.