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

Depression Clinical Trial

— POKAL-PSY  

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Episode
• Depressive Symptoms
• Disease
• Major Depressive Disorder

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

External Links

•   POKAL Website