Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431009
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-02-23
Brief Title:
The Danish Region Midt Schizophrenia Cohort
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RMS
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
Detailed 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 15 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 patientsyear 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 ie 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 patients 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
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 patientsyear 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 ie 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None