P4D - Personalized, Predictive, Precise & Preventive Medicine for Major Depression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Major Depressive Disorder
- Sponsor
- Hannover Medical School
- Enrollment
- 1000
- Primary Endpoint
- Remission after 7 weeks of treatment
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Remission after 7 weeks of treatment
Time Frame: 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 Outcomes
- Recording of psychometric changes in the clinical course of treatment(Baseline and Follow-up (Week 7))
- Frequency of other concomitant treatments (e.g., additional psychotherapeutic treatment)(Follow-up (Week 7))
- 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.)
- 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.)
- Patient-doctor relationship(Baseline and Follow-up (Week 7))