Table 1 Inclusion and exclusion criteria

Inclusion criteria

Age

 ≥ 18– ≤ 70

Sex

Male, female, or diverse

Major depressive episode according to ICD-10 (F32.2–3, F33.2–3)

Single or recurrent episodes, as confirmed by the DIPS

Symptom severity

Severe (MADRS ≥ 34)

Modification in the therapeutic regimen is being considered

e.g., change of AD or change to neuromodulatory therapy

First MDD episode < 50 years

Capacity for consent

Written informed consent

Exclusion criteria

 Acute suicidality

 Accommodation according to state law

(e.g., §16/17 Nds. PsychKG)

 Persistent depressive disorder (PDD) (ICD-10: F34.1)

 (Lifetime) diagnoses of

Dementia, schizophrenia, schizoaffective disorder, bipolar disorder, substance addiction with currently necessary detoxification

 Simultaneous participation in other clinical trials that are not conducted within the scope of the P4D project