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Not yet recruitingNCT05547711POKAL-PSYUpdated Sep 21, 2022

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

An interventional study of drawing blood in Depressive Disorder, Depression and Depressive Symptoms, sponsored by Julia Eder. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-21.

Sponsored by Julia Eder · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
950
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Depressive Disorder
  • Depression
  • Depressive Symptoms
  • Depressive Episode
  • Major Depressive Disorder
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 950 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

This is the only study on the registry with Julia Eder as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
950 participants (estimated)

Study arms

  • Active comparator
    Patients with depression

    Diagnostic Test: drawing blood

  • Active comparator
    Healthy controls

    Diagnostic Test: drawing blood

Interventions

  • Diagnostic testdrawing blood

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

    Also known as: bioimpedance scale, measurement of heartrate variability

06

What researchers measure

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

  5. weight

    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

  5. weight

    Time frame: 5 years

07

Study locations

1 site
08

References and documents

Related links

Individual participant data

Plan to share: Yes — Data will be completely anonymised before conducting statistical analysis. First data will be shared within the graduate college. After fist publications other researches can use the data upon reasonable request

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05547711
Lead sponsor
Julia Eder
Responsible party
Julia Eder (Associate Physician, LMU Klinikum) — Sponsor-investigator
First posted
Sep 21, 2022
Start date
Oct 15, 2022 (estimated)
Primary completion
Oct 15, 2027 (estimated)
Completion
Oct 15, 2032 (estimated)
Last update
Sep 21, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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