Back to resultsPrediction and Validation of Unipolar Depression With Psychosocial-somatic Markers in a Naturalistic Cohort Recruited in an Outpatient Setting (POKAL-PSY)
Primary Purpose
Depressive Disorder, Depression, Depressive Symptoms
Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
drawing blood
Sponsored by
About this trial
This is an interventional other trial for Depressive Disorder
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
Sites / Locations
- Department of Psychiatry and Psychotherapy, University Hospital LMU
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients with depression
Healthy controls
Arm Description
Outcomes
Primary Outcome Measures
Changes in GAF
Changes in MADRS
Alpha-1-Antitrypsin
IGF-1
weight
Secondary Outcome Measures
Changes in GAF
Changes in MADRS
alpha-1-Antitrypsin
IGF-1
weight
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05547711
Brief Title
Prediction and Validation of Unipolar Depression With Psychosocial-somatic Markers in a Naturalistic Cohort Recruited in an Outpatient Setting
Acronym
POKAL-PSY
Official Title
Prediction and Validation of Unipolar Depression With Psychosocial-somatic Markers in a Naturalistic Cohort Recruited in an Outpatient Setting
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2022 (Anticipated)
Primary Completion Date
October 15, 2027 (Anticipated)
Study Completion Date
October 15, 2032 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Julia Eder
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Depression, Depressive Symptoms, Depressive Episode, Major Depressive Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
At inclusion mentally healthy and patients with a depression are monitored for five years. After study inclusion participants will be seen after four weeks and then annually for five years.
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
950 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with depression
Arm Type
Active Comparator
Arm Title
Healthy controls
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
drawing blood
Other Intervention Name(s)
bioimpedance scale, measurement of heartrate variability
Intervention Description
drawing blood annually measurement of heartrate variability annually determine weight with a bioimpedance scale
Primary Outcome Measure Information:
Title
Changes in GAF
Time Frame
4 Weeks
Title
Changes in MADRS
Time Frame
4 Weeks
Title
Alpha-1-Antitrypsin
Time Frame
1 year
Title
IGF-1
Time Frame
1 year
Title
weight
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Changes in GAF
Time Frame
5 years
Title
Changes in MADRS
Time Frame
5 years
Title
alpha-1-Antitrypsin
Time Frame
5 years
Title
IGF-1
Time Frame
5 years
Title
weight
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, University Hospital LMU
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80336
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Eder, MD
Phone
089440055639
Email
PSY.Pokal-Studie@med.uni-muenchen.de
First Name & Middle Initial & Last Name & Degree
Lisa Hattenkofer, M.Sc.
Phone
089440055318
Email
PSY.Pokal-Studie@med.uni-muenchen.de
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Links:
URL
https://pokal-kolleg.de/
Description
POKAL Website
Learn more about this trial
Prediction and Validation of Unipolar Depression With Psychosocial-somatic Markers in a Naturalistic Cohort Recruited in an Outpatient Setting
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