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

September 19, 2022 updated by: Julia Eder
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

950

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy controls
Diagnostic test: drawing blood
drawing blood annually measurement of heartrate variability annually determine weight with a bioimpedance scale
Other Names:
  • bioimpedance scale
  • measurement of heartrate variability
Active Comparator: Patients with depression
Diagnostic test: drawing blood
drawing blood annually measurement of heartrate variability annually determine weight with a bioimpedance scale
Other Names:
  • bioimpedance scale
  • measurement of heartrate variability

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in GAF
Time Frame: 4 Weeks
4 Weeks
Changes in MADRS
Time Frame: 4 Weeks
4 Weeks
Alpha-1-Antitrypsin
Time Frame: 1 year
1 year
IGF-1
Time Frame: 1 year
1 year
weight
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in GAF
Time Frame: 5 years
5 years
Changes in MADRS
Time Frame: 5 years
5 years
alpha-1-Antitrypsin
Time Frame: 5 years
5 years
IGF-1
Time Frame: 5 years
5 years
weight
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Julia Eder

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2022

Primary Completion (Anticipated)

October 15, 2027

Study Completion (Anticipated)

October 15, 2032

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

September 19, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-0637
  • DFG-GRK 2621 POKAL (Other Grant/Funding Number: Prof. Dr.med. Jochen Gensichen)
  • DRKS00030203 (Other Identifier: German Clinical Trials Register)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

will be determined

IPD Sharing Access Criteria

proposal

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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