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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJulia Eder

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

(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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • drawing blood

    Diagnostic test

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

Treatment groups

950 Participants
are divided into 2 treatment groups
Group A: Patients with depressionActive comparator 1 intervention
Group B: Healthy controlsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in GAF

Time frame
4 Weeks
2

Changes in MADRS

Time frame
4 Weeks
3

Alpha-1-Antitrypsin

Time frame
1 year
4

IGF-1

Time frame
1 year

Secondary outcomes

1

Changes in GAF

Time frame
5 years
2

Changes in MADRS

Time frame
5 years
3

alpha-1-Antitrypsin

Time frame
5 years
4

IGF-1

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Julia Eder

Lead sponsor

LMU Klinikum

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: