F20 F22 F23 F25 F28 F29
Conditions
Interventions
Group 1: We will include individuals with schizophrenia-spectrum disorders (SSD) who are admitted to a psychiatric hospital. The patients will be included, and baseline investigations will be conducte
Sponsors
Klinik für Psychiatrie und Psychotherapie der LMU München
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: The following inclusion criteria will apply: - Obligatory participation to Munich Mental Health Biobank (Project number: 18-716); - Diagnosis of schizophrenia-spectrum disorders, based on DSM-V, validated with the M.I.N.I. interview; - Age: =18 years and = 65 years; - Ability to participate in the extensive phenotyping of the CDP-STAR study; - Ability to provide informed consent alone or, if necessary for patients who have a legal guardian for the task area “health”, together with the patients and the respective legal guardian. The legal guardians can be informed and will also sign the consent form or give verbal consent after being informed by the study physician. Signatures by scan or fax will also be accepted; - The ability to provide informed consent of patients with acute psychosis will be validated by a study-independent physician.
Exclusion criteria
Exclusion criteria: The following exclusion criteria will apply: - Patients with a primary psychiatric diagnosis other than defined above; - Age: 65 years; - Patients who are not suitable for the study in the opinion of the investigator; - Patients with acute danger to self and others (e.g. acute suicidality); - Coercive treatment or forced placement in a psychiatric hospital at the time of study inclusion; - Patients with a relevant comorbidity of the central nervous system (i.e. dementia, multiple sclerosis, epilepsy) or organic psychosis/affective disorder; - Patients that are not able to provide informed consent; - Contraindications for a cranial magnetic resonance imaging (MRI) such as pacemaker, ferromagnetic implants, or insulin pumps (applies only for the MRI assessment); - For the subgroup of participants, on whom DCE-MRI will be performed, contraindications for a cranial dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI): acute kidney failure (GFR 130 µmol/l) or previous allergy/intolerance to a Gadolinium contrast medium or participants with known impaired kidney function, known metabolic alkalosis and hypokalemia, COPD or heart failure will not be included in the study (only applies for the participants, who receive a DCE-MRI assessment).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is the evaluation of the prognostic capabilities (measured by the area under the curve (AUC) in receiver operator characteristic (ROC) curves) of biomarker candidates (e.g. structural connectivity) regarding acute treatment response in patients with schizophrenia-spectrum disorders 4 weeks after inclusion. Short-term treatment response would be defined as follows: =25% symptom reduction in PANSS total score compared to baseline score. To ensure that our results won’t be driven by idiosyncrasies in how we define treatment response, we will include two other definitions commonly used in the field: =50% symptom reduction in PANSS total score and percentage change with baseline correction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the prognostic capabilities of candidate biomarkers regarding further longitudinal outcomes such as remission and recovery. Identification of biologically driven subgroups within the schizophrenia-spectrum disorders. Exploring neurobiological correlates of and mechanisms behind treatment response, treatment resistance, symptomatic remission and recovery. | — |
Countries
Germany
Contacts
Public ContactVladislav Yakimov
Klinik für Psychiatrie und Psychotherapie der LMU München
Outcome results
None listed