F32.2 F32.3 F33.2 F33.3
Conditions
Interventions
Group 1: 128 patients and their treating physicians receive information about the BDNF IV CpG-87 status of the patient.
Group 2: 128 patients and treating physicians do not receive information about t
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: - Severity of symptoms: Severe (HDRS-24 = 25) - Change of therapy / alteration of medication therapy - First depressive episode before the age of 50 - Signed informed consent - Capacity to provide consent
Exclusion criteria
Exclusion criteria: - Acute suicidality - Involuntary placement according to state law (e.g., §16/17 Nds. PsychKG) - Persistent depressive disorder (PDD) - Following diagnoses in medical history: Dementia, schizophrenia, schizoaffective disorder, bipolar disorder, substance dependence with current necessary detoxification - Simultaneous participation in other clinical studies not conducted within the scope of the P4D project
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two (co-)primary endpoints: 1.: Co-primary Efficacy Endpoint: Remission rate of depressive symptoms 6 weeks post-randomization determined by an HDRS-24 total score = 10. 2.: Co-primary Tolerance Endpoint: Rate of adverse events (AE) within 6 weeks post-randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Remission 10 weeks after randomization (HDRS-24 total scores = 10), adverse events 10 weeks after randomization, prescription rate of antidepressants, frequency of changes in therapy regimens during study participation; frequency of specific psychotherapy application; frequency of additional treatment options' utilization; frequency and reasons for study discontinuations; attitudes (acceptance, fears, and prejudices) towards biomarker-guided investigations and technical procedures in the population (representative population survey). Patient-physician relationship. | — |
Countries
Germany
Contacts
Public ContactHelge Frieling
Medizinische Hochschule Hannover
Outcome results
None listed