Clinical Deep Phenotyping of Treatment Response in Schizophrenia (CDP-STAR) Study

• Conditions: F28; F29; F20; F22; F23; F25; Schizophrenia; Persistent delusional disorders; Acute and transient psychotic disorders; Schizoaffective disorders

• Registration Number: DRKS00034820
• Lead Sponsor: Klinik für Psychiatrie und Psychotherapie der LMU München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 352

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

The following exclusion criteria will apply:
- Patients with a primary psychiatric diagnosis other than defined above;
- Age: < 18 years and > 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 < 30 ml/min or serum-creatinine > 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).

Study & Design

• Study Type: observational
• Study Design: Not specified