NCT05547711

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
950

participants targeted

Target at P75+ for not_applicable

Timeline
79mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Oct 2022Oct 2032

First Submitted

Initial submission to the registry

September 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
24 days until next milestone

Study Start

First participant enrolled

October 15, 2022

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2027

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2032

Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

5 years

First QC Date

September 15, 2022

Last Update Submit

September 19, 2022

Conditions

Depressive DisorderDepressionDepressive SymptomsDepressive EpisodeMajor Depressive Disorder

Outcome Measures

Primary Outcomes (5)

  • Changes in GAF

    4 Weeks

  • Changes in MADRS

    4 Weeks

  • Alpha-1-Antitrypsin

    1 year

  • IGF-1

    1 year

  • weight

    1 year

Secondary Outcomes (5)

  • Changes in GAF

    5 years

  • Changes in MADRS

    5 years

  • alpha-1-Antitrypsin

    5 years

  • IGF-1

    5 years

  • weight

    5 years

Study Arms (2)

Patients with depression

ACTIVE COMPARATOR
Diagnostic Test: drawing blood

Healthy controls

ACTIVE COMPARATOR
Diagnostic Test: drawing blood

Interventions

drawing bloodDIAGNOSTIC_TEST

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

Also known as: bioimpedance scale, measurement of heartrate variability
Healthy controlsPatients with depression

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, University Hospital LMU

Munich, Bavaria, 80336, Germany

Location

Related Links

MeSH Terms

Conditions

Depressive DisorderDepressionDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Physician

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 21, 2022

Study Start

October 15, 2022

Primary Completion (Estimated)

October 15, 2027

Study Completion (Estimated)

October 15, 2032

Last Updated

September 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL
Time Frame
will be determined
Access Criteria
proposal

Locations

DE(1)