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Not yet recruiting NCT05547711

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

No phase Interventional Depressive Disorder Depression Depressive Symptoms Depressive Episode

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: drawing blood.
Who it may be relevant to
Registry conditions: Depressive Disorder, Depression, Depressive Symptoms, Depressive Episode. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Primary outcome measures

  • Changes in GAF [Time frame: 4 Weeks]
  • Changes in MADRS [Time frame: 4 Weeks]
  • Alpha-1-Antitrypsin [Time frame: 1 year]
  • IGF-1 [Time frame: 1 year]
  • weight [Time frame: 1 year]
Secondary outcome measures (5)
  • Changes in GAF [Time frame: 5 years]
  • Changes in MADRS [Time frame: 5 years]
  • alpha-1-Antitrypsin [Time frame: 5 years]
  • IGF-1 [Time frame: 5 years]
  • weight [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Germany · 1 center
  • Department of Psychiatry and Psychotherapy, University Hospital LMU — Munich

Identifiers

NCT: NCT05547711 · 22-0637 · DFG-GRK 2621 POKAL · DRKS00030203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗