Personalized, Predictive, Precise & Preventive Medicine for Major Depression

Study Overview
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Brief Summary
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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.

Official Title
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P4D - Personalized, Predictive, Precise & Preventive Medicine for Major Depression

Conditions
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Major Depressive Disorder, Persistent Depressive Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MDD: ICD-10: F32.1-3, F33.1-3 first or recurrent depressive episode (confirmed by MINI-DIPS) and/or PDD: F34.1 Symptom severity: Moderate to severe (MADRS ≥ 20). First depressive episode before 50 years of age Signed informed consent form Capacity to consent Exclusion Criteria: Acute Suicidality Placement according to state law (e.g. §16/17 Nds. PsychKG) The following diagnoses in the life course: Dementia, schizophrenia, schizoaffective disorder, bipolar disorder, substance dependence with currently necessary detoxification Concurrent participation in other clinical trials that are not being conducted within the framework of the P4D project

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission after 7 weeks of treatment | The Montgomery-Asberg-Depression-Scale (MADRS) is used to measure the severity of depressive symptoms. A score lower 7 is the cut-off. | Baseline and Follow-up (Week 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recording of psychometric changes in the clinical course of treatment | 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). | Baseline and Follow-up (Week 7) | 
| Frequency of other concomitant treatments (e.g., additional psychotherapeutic treatment) | Psychotherapy sessions (individual and group therapy) are recorded for 7 weeks. Alternative treatments (e.g. transcranial magnetic stimulation and electroconvulsive therapy) are also recorded. | Follow-up (Week 7) | 
| Treatment/study dropout rates | Dropout rates are recorded with reasons. | 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. | 
| Attitudes (acceptance, fears, and prejudices) regarding biomarker-guided examinations and technical procedures among the population | Representative population survey | The survey will be conducted over a 2-week period in late August / early September 2023. | 
| Patient-doctor relationship | The Patient-Doctor-Relationship-Questionnaire (PDRQ-9) is used to assess the quality of the therapeutic relationship. | Baseline and Follow-up (Week 7) |