Prediction and Validation of Unipolar Depression With Psychosocial-somatic Markers in a Naturalistic Cohort Recruited in an Outpatient Setting (POKAL-PSY)

Julia Eder

Status

Not yet enrolling

Conditions

Depressive Symptoms

Major Depressive Disorder

Depressive Episode

Depression

Depressive Disorder

Treatments

Diagnostic Test: drawing blood

Study type

Interventional

Funder types

Other

Identifiers

NCT05547711

22-0637

DRKS00030203 (Other Identifier)

DFG-GRK 2621 POKAL (Other Grant/Funding Number)

Details and patient eligibility

About

The POKAL-PSY project is a study that monitors participants for five years. The goal of the study is to identify distinguishable subtypes of depression on the basis of biomarkers and to gain insight into their prognostic significance.

Enrollment

950 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

(PHQ>8) if depressed
Subjects of any sex aged between 18-70
Sufficient ability to speak and understand the german language
Ability to understand and sign the informed consent form

Exclusion criteria

Cognitive impairment that interferes with reliable completion of questionnaires or answering questions
Presence of manic episode, bipolar disorder, Schizophrenia or schizoaffective disorder (as well as other diseases in the F2 domain in the ICD), active eating disorder, active drug or alcohol dependence syndrome
Presence of uncontrolled systemic disease (e.g. autoimmune disease), uncontrolles somatic (other than metabolic or cardiovascular)/ neurologic diseases, current or recent (last month) physical trauma
Patient with acute suicidal ideation
known deficiency of alpha-1-antitrypsin
pregnant or lactating women