MedPath

Personalized, predictive, precise & preventive medicine for Major Depressio

Conditions
Major Depressive Disorder MDD (DSM-5) / rezidivierende depressive Störung, gegenwärtig mittelgradig bis schwer (ICD-10: F32.1-3 & F33.1-3) and/or Persistend Depressive Disorder (PDD
ICD-10: F34.1)
F32
F33
F34.1
Depressive episode
Recurrent depressive disorder
Dysthymia
Registration Number
DRKS00032215
Lead Sponsor
Medizinische Hochschule Hannover
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
1000
Inclusion Criteria

MDD: F32.1-3, F33.1-3 first or recurrent depressive episode (confirmed by MINI-DIPS confirmed) 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 & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
remission after 7 weeks of treatment (MADRS = 7
Secondary Outcome Measures
NameTimeMethod
1. recording of psychometric changes in the clinical course of treatment<br>2. frequency of other concomitant treatments (e.g., additional psychotherapeutic treatment)<br>3. treatment/study dropout rates<br>4. expectations and attitudes of patients and practicing physicians towards treatment with antidepressants and the use of biomarkers to guide therapy (subproject Stiftung Deutsche Depressionshilfe and Suicide Prevention)<br>5. patient:in-treatment:in relationship
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