Personalized, Predictive, Precise & Preventive Medicine for Major Depression

Major Depressive Disorder Clinical Trial

— P4D  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06027177
• Other study ID #: P4D_cohort
• Secondary ID: DRKS00032215
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: August 2025

Study information

• Verified date: September 2023
• Source: Hannover Medical School
• Contact: Helge Frieling, Prof. Dr.med
• Phone: +49 511 532-2427
• Email: frieling.helge[@]mh-hannover.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Persistent Depressive Disorder

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Hannover Medical School	Goethe University, University Hospital Schleswig-Holstein, University Medicine Greifswald, Wuerzburg University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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.
Secondary	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.
Secondary	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)