Personalized, Predictive, Precise & Preventive Medicine for Major Depression (P4D)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Major Depressive Disorder; Persistent Depressive Disorder

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Helge Frieling, Prof. Dr.med; Phone Number: +49 511 532-2427; Email: frieling.helge@mh-hannover.de
• Study Contact Backup: Name: Hannah B Maier, Dr. med.; Phone Number: +49 176 1532-8329; Email: maier.hannah@mh-hannover.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Collaborators: Goethe University; University Medicine Greifswald; University Hospital Schleswig-Holstein; Wuerzburg University Hospital
• Investigators: Study Chair: Helge Frieling, Prof. Dr.med, Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: P4D_cohort; DRKS00032215 (Registry Identifier: DRKS German Clinical Trials Register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing is planned.
• IPD Sharing Time Frame: Data will be kept pseudonymised for 10 years and then anonymised.
• IPD Sharing Access Criteria: Upon individual request, data may be made available before this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No