Personalized, Predictive, Precise & Preventive Medicine for Major Depression

Not yet recruiting

• Conditions: Major Depressive Disorder; Persistent Depressive Disorder

• Registration Number: NCT06027177
• Lead Sponsor: Hannover Medical School

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-22
• Status Verified: 2023-09
• Study Start: 2023-09
• Study First Submitted QC: 2023-09-05
• Last Update Submitted: 2023-09-05
• Study First Posted: 2023-09-07
• Last Update Posted: 2023-09-07
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.