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Search / Trial NCT05547711

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

Launched by JULIA EDER · Sep 19, 2022

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

The POKAL-PSY project is a long-term study that aims to understand different types of depression and how they can be identified using specific biological markers. Over a period of five years, researchers will observe and collect data from participants to learn more about how these markers can help predict the course of depression. This study is important because it could lead to better ways to diagnose and treat depression based on individual needs.

To be eligible for this study, participants must be between 18 and 70 years old, able to speak and understand German, and have a certain level of depression as measured by a questionnaire. However, individuals with certain mental health conditions, cognitive impairments, or other serious health issues, such as active substance dependence or recent physical trauma, won’t be able to participate. If chosen, participants can expect regular check-ins and assessments over the five years to track their symptoms and overall well-being. Remember, this study is still in the planning stage and is not yet recruiting participants.

Gender

ALL

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

About Julia Eder

Julia Eder is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative study designs and rigorous ethical standards. With a focus on enhancing therapeutic development across various therapeutic areas, Julia Eder collaborates with healthcare professionals, regulatory bodies, and research institutions to ensure the efficient and effective execution of clinical trials. By prioritizing patient safety and data integrity, Julia Eder strives to contribute to the advancement of science and the discovery of new treatment options.

Locations

Munich, Bavaria, Germany

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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