Depressive DisorderPOKAL-PSYNCT05547711
Prediction and Validation of Unipolar Depression With Psychosocial-somatic Markers in a Naturalistic Cohort Recruited in an Outpatient Setting
A study testing drawing blood in people with Depressive Disorder and Depression, run by Julia Eder at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Depression, Depressive Symptoms
- What is being tested?
- drawing blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 950 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2022to 15 Oct 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Department of Psychiatry and Psychotherapy, University Hospital LMU
Munich, Bavaria, 80336
Julia Eder, MD, 089440055639, PSY.Pokal-Studie@med.uni-muenchen.de
Lisa Hattenkofer, M.Sc., 089440055318, PSY.Pokal-Studie@med.uni-muenchen.de
About this study
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.
- Conditions
- Depressive Disorder, Depression, Depressive Symptoms, Depressive Episode, Major Depressive Disorder
- Being tested
- drawing blood
- Medical subject headings
- Depressive Disorder, Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drawing bloodDiagnostic test
Also called bioimpedance scale, measurement of heartrate variability
drawing blood annually measurement of heartrate variability annually determine weight with a bioimpedance scale
| Study group | Role | What they receive |
|---|---|---|
| Patients with depression | Active comparator | Not described Receives: Diagnostic Test: drawing blood |
| Healthy controls | Active comparator | Not described Receives: Diagnostic Test: drawing blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in GAF
Measured: 4 Weeks
Changes in MADRS
Measured: 4 Weeks
Alpha-1-Antitrypsin
Measured: 1 year
IGF-1
Measured: 1 year
weight
Measured: 1 year
Secondary outcomes (5)
Changes in GAF
Measured: 5 years
Changes in MADRS
Measured: 5 years
alpha-1-Antitrypsin
Measured: 5 years
IGF-1
Measured: 5 years
weight
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start15 Oct 2022 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Julia Eder
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julia Eder, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547711
- Sponsor's protocol ID
- 22-0637
- Other IDs
- DFG-GRK 2621 POKAL, DRKS00030203
- Acronym
- POKAL-PSY
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Validation of Unipolar Depression With Psychosocial-somatic Markers in a Naturalistic Cohort Recruited in an Outpatient Setting
- ClinicalTrials.gov ID
- NCT05547711
- Acronym / sponsor ID
- POKAL-PSY / 22-0637
- Conditions
- Depressive Disorder, Depression, Depressive Symptoms, Depressive Episode, Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Julia EderUniversity, hospital or other
- Study start
- 15 Oct 2022 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Oct 2032 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients with depression | Active comparator | Diagnostic Test: drawing blood |
| Healthy controls | Active comparator | Diagnostic Test: drawing blood |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drawing bloodAlso: bioimpedance scale, measurement of heartrate variabilitydrawing blood annually measurement of heartrate variability annually determine weight with a bioimpedance scale | Diagnostic test | Healthy controls, Patients with depression |
Primary outcome
Changes in GAF
Time frame: 4 Weeks
Changes in MADRS
Time frame: 4 Weeks
Alpha-1-Antitrypsin
Time frame: 1 year
IGF-1
Time frame: 1 year
weight
Time frame: 1 year
5 secondary outcomes
Changes in GAF
Time frame: 5 years
Changes in MADRS
Time frame: 5 years
alpha-1-Antitrypsin
Time frame: 5 years
IGF-1
Time frame: 5 years
weight
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- POKAL WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Department of Psychiatry and Psychotherapy, University Hospital LMU
Munich, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drawing blood in people with Depressive Disorder and Depression, run by Julia Eder at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in GAF (time frame: 4 Weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2022.