Depression, Depressive Disorder, Depressive Episode, Depressive Symptoms, Major Depressive Disorder
Conditions
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.
Interventions
DIAGNOSTIC_TESTdrawing blood
drawing blood annually measurement of heartrate variability annually determine weight with a bioimpedance scale
Sponsors
Julia Eder
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| weight | 1 year |
| Changes in GAF | 4 Weeks |
| Changes in MADRS | 4 Weeks |
| Alpha-1-Antitrypsin | 1 year |
| IGF-1 | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Changes in GAF | 5 years |
| Changes in MADRS | 5 years |
| alpha-1-Antitrypsin | 5 years |
| IGF-1 | 5 years |
| weight | 5 years |
Countries
Germany
Outcome results
None listed