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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depressive Disorder, Depression, Depressive Symptoms, Depressive Episode, Major Depressive Disorder

Intervention / Treatment
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* Diagnostic Test: drawing blood


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: At inclusion mentally healthy and patients with a depression are monitored for five years. After study inclusion participants will be seen after four weeks and then annually for five years.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with depression<br> | Diagnostic Test: drawing blood<br>* drawing blood annually measurement of heartrate variability annually determine weight with a bioimpedance scale<br>* Other names: measurement of heartrate variability;|
| Active Comparator: Healthy controls<br> | Diagnostic Test: drawing blood<br>* drawing blood annually measurement of heartrate variability annually determine weight with a bioimpedance scale<br>* Other names: measurement of heartrate variability;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in GAF |  | 4 Weeks | 
| Changes in MADRS |  | 4 Weeks | 
| Alpha-1-Antitrypsin |  | 1 year | 
| IGF-1 |  | 1 year | 
| weight |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in GAF |  | 5 years | 
| Changes in MADRS |  | 5 years | 
| alpha-1-Antitrypsin |  | 5 years | 
| IGF-1 |  | 5 years | 
| weight |  | 5 years |