Personalized, Predictive, Precise & Preventive Medicine for Major Depression

NCT06027177 | Unknown

• 2 other identifiers: P4D_cohortDRKS00032215
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder; Persistent Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hannover Medical School: lead
• University Medicine Greifswald: collaborator
• Wuerzburg University Hospital: collaborator
• Goethe University: collaborator
• University Hospital Schleswig-Holstein: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are used for a variety of purposes. In addition to standard clinical laboratory tests, genetic (nanopore sequencing) and epigenetic (miRNA, methylation) tests will be performed. In addition, drug levels will be monitored regularly.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Helge Frieling, Prof. Dr.med

  Hannover Medical School

  STUDY CHAIR

Central Study Contacts

Helge Frieling, Prof. Dr.med

CONTACT

+49 511 532-2427; frieling.helge@mh-hannover.de

Hannah B Maier, Dr. med.

CONTACT

+49 176 1532-8329; maier.hannah@mh-hannover.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: September 7, 2023
• Study Start: September 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be kept pseudonymised for 10 years and then anonymised.
• Access Criteria: Upon individual request, data may be made available before this time.