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NCT Number: NCT05547711

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

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.

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Key information

Conditions

Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder, Major Depressive Episode Depressive Symptoms Major Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

drawing blood

Diagnostic Test

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

Other names: bioimpedance scale, measurement of heartrate variability

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

Sponsors and collaborators

Lead sponsor

Julia Eder

Other

Registry information

Acronym: POKAL-PSY

Important dates

Study start
2022
Primary completion
2027
Study completion
2032
First posted
Sep 21, 2022
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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