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

Not Applicable

Not yet recruiting

• Conditions: Depression; Depressive Disorder; Depressive Episode; Depressive Symptoms; Major Depressive Disorder
• Interventions: Diagnostic Test: drawing blood

• Registration Number: NCT05547711
• Lead Sponsor: Julia Eder

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-19
• Last Update Submitted: 2022-09-19
• Study First Posted: 2022-09-21
• Last Update Posted: 2022-09-21
• Study Start: 2022-10-15
• Primary Completion: 2027-10-15
• Study Completion: 2032-10-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 950

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy controls	drawing blood	-
Patients with depression	drawing blood	-

Primary Outcome Measures

Name	Time	Method
Changes in MADRS	4 Weeks
Alpha-1-Antitrypsin	1 year
Changes in GAF	4 Weeks
IGF-1	1 year
weight	1 year

Secondary Outcome Measures

Name	Time	Method
Changes in MADRS	5 years
alpha-1-Antitrypsin	5 years
IGF-1	5 years
weight	5 years
Changes in GAF	5 years

Trial Locations

Locations (1)

Department of Psychiatry and Psychotherapy, University Hospital LMU; 🇩🇪 Munich, Bavaria, Germany