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

Hannover Medical School (MHH)

Status: Not yet enrolling

Conditions: Major Depressive Disorder; Persistent Depressive Disorder

Study type: Observational

Funder types: Other

Identifiers

NCT06027177

P4D_cohort

DRKS00032215 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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