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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05547711
Other study ID # 22-0637
Secondary ID DFG-GRK 2621 POK
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 15, 2022
Est. completion date October 15, 2032

Study information

Verified date September 2022
Source LMU Klinikum
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 950
Est. completion date October 15, 2032
Est. primary completion date October 15, 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Diagnostic Test:
drawing blood
drawing blood annually measurement of heartrate variability annually determine weight with a bioimpedance scale

Locations

Country Name City State
Germany Department of Psychiatry and Psychotherapy, University Hospital LMU Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
Julia Eder

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in GAF 4 Weeks
Primary Changes in MADRS 4 Weeks
Primary Alpha-1-Antitrypsin 1 year
Primary IGF-1 1 year
Primary weight 1 year
Secondary Changes in GAF 5 years
Secondary Changes in MADRS 5 years
Secondary alpha-1-Antitrypsin 5 years
Secondary IGF-1 5 years
Secondary weight 5 years
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