Clinical trial NCT06027177: Personalized, Predictive, Precise & Preventive Medicine for Major Depression
Official title: P4D - Personalized, Predictive, Precise & Preventive Medicine for Major Depression
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Major Depressive Disorder
Persistent Depressive Disorder
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: University Medicine Greifswald
name: Wuerzburg University Hospital
name: Goethe University
name: University Hospital Schleswig-Holstein
First posted: 2023-09-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate to severe depressive disorder, aged between 18 and 70 years, who are undergoing inpatient treatment will be recruited. Patients should fulfil the inclusion criteria. All patients who meet the criteria are given information by a doctor and have the opportunity to ask further questions. Their participation in the study is voluntary and they give their written informed consent.

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.


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

Primary outcomes:
measure: Remission after 7 weeks of treatment
timeFrame: Baseline and Follow-up (Week 7)
Secondary outcomes:
measure: Recording of psychometric changes in the clinical course of treatment
timeFrame: Baseline and Follow-up (Week 7)
measure: Frequency of other concomitant treatments (e.g., additional psychotherapeutic treatment)
timeFrame: Follow-up (Week 7)
measure: Treatment/study dropout rates
timeFrame: 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.
measure: Attitudes (acceptance, fears, and prejudices) regarding biomarker-guided examinations and technical procedures among the population
timeFrame: The survey will be conducted over a 2-week period in late August / early September 2023.
measure: Patient-doctor relationship
timeFrame: Baseline and Follow-up (Week 7)
Other outcomes:
Locations:
Study officials:
affiliation: Hannover Medical School
name: Helge Frieling, Prof. Dr.med
role: STUDY_CHAIR
References: