P4D: Personalized, Predictive, Precise & Preventive Medicine for Major Depression
Study Details
Study Description
Brief Summary
Depressive disorders are among the most common psychiatric disorders. However, this disorder is multifaceted, as are its etiological factors, and is not yet fully understood. Within the framework of the P4D study, 1000 patients with depression will be comprehensively examined. In addition to the recording of psychological factors by means of questionnaires and third-party assessments, imaging and electrophysiological procedures (functional and structural MRI, EEG) are used to assess brain structure and function. In addition, blood is drawn from the subjects to analyze these samples for various biological markers (e.g., genetics). Drug level measurements are also performed.
The goal is to perform an in-depth characterization (phenotyping) of individuals with a depressive disorder. These findings could be used to individualize and improve therapy for depressive disorders.
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Study Design
Outcome Measures
Primary Outcome Measures
- Remission after 7 weeks of treatment [Baseline and Follow-up (Week 7)]
The Montgomery-Asberg-Depression-Scale (MADRS) is used to measure the severity of depressive symptoms. A score lower 7 is the cut-off.
Secondary Outcome Measures
- Recording of psychometric changes in the clinical course of treatment [Baseline and Follow-up (Week 7)]
A range of psychometric information is collected. These include questionnaires, third party ratings and a cognitive assessment, as well as neuroimaging (functional and structural MRI), neurophysiology (EEG) and polysomnography (PSG).
- Frequency of other concomitant treatments (e.g., additional psychotherapeutic treatment) [Follow-up (Week 7)]
Psychotherapy sessions (individual and group therapy) are recorded for 7 weeks. Alternative treatments (e.g. transcranial magnetic stimulation and electroconvulsive therapy) are also recorded.
- Treatment/study dropout rates [Drop-out rates are collected throughout the data collection period, over two years. Starting at study enrollment of the first subject until complete completion of the last subject.]
Dropout rates are recorded with reasons.
- Attitudes (acceptance, fears, and prejudices) regarding biomarker-guided examinations and technical procedures among the population [The survey will be conducted over a 2-week period in late August / early September 2023.]
Representative population survey
- Patient-doctor relationship [Baseline and Follow-up (Week 7)]
The Patient-Doctor-Relationship-Questionnaire (PDRQ-9) is used to assess the quality of the therapeutic relationship.
Eligibility Criteria
Criteria
Inclusion Criteria:
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MDD: ICD-10: F32.1-3, F33.1-3 first or recurrent depressive episode (confirmed by MINI-DIPS) and/or PDD: F34.1
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Symptom severity: Moderate to severe (MADRS ≥ 20).
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First depressive episode before 50 years of age
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Signed informed consent form
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Capacity to consent
Exclusion Criteria:
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Acute Suicidality
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Placement according to state law (e.g. §16/17 Nds. PsychKG)
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The following diagnoses in the life course: Dementia, schizophrenia, schizoaffective disorder, bipolar disorder, substance dependence with currently necessary detoxification
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Concurrent participation in other clinical trials that are not being conducted within the framework of the P4D project
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hannover Medical School
- University Medicine Greifswald
- Wuerzburg University Hospital
- Goethe University
- University Hospital Schleswig-Holstein
Investigators
- Study Chair: Helge Frieling, Prof. Dr.med, Hannover Medical School
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P4D_cohort
- DRKS00032215