DepressionNCT05427578
Brain Markers of Depression Vulnerability: the Case of Prefrontal Haemodynamic Response
An observational study of Depression, run by Dr Georg Kranz at 1 site in Hong Kong.
Trial summary
Functional near infrared spectroscopy (fNIRS) offers a cheap and reliable tool to investigate prefrontal brain activation in the healthy and diseased human brain. As such, fNIRS bears great potential as a diagnostic tool for clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- fNIRS measurement
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2021to 29 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: rMDD group: People who had major depressive disorders now fully remitted HCr group: Healthy control group with a high risk of depression, refer to as healthy volunteers who have a 1st-degree relative with MDD in this study. HCnr group: Healthy control group with a low risk of depression, refer to as healthy volunteers who have no a 1st-degree relative with MDD in this study.
Who may be able to join
- Mini-mental state examination (MMSE) > 24
Who cannot join
- Current diagnosis of psychiatric disorders, such as depression, anxiety, schizophrenia, or autism
- current or past diagnosis of neurological disorders, such as head injuries, strokes, encephalitis, epilepsy, Parkinson's, or Alzheimer's
Trial locations and contacts
1 site in 1 country.
About this study
Functional near infrared spectroscopy (fNIRS) offers a cheap and reliable tool to investigate prefrontal brain activation in the healthy and diseased human brain. As such, fNIRS bears great potential as a diagnostic tool for clinical practice. Research indicates that fNIRS, together with a relatively simple task to activate the prefrontal cortex, the so-called verbal fluency task (VFT), elucidates prefrontal dysfunction in major depressive disorder (MDD). This finding can potentially serve as an imaging marker for disease pathology, even when depressive symptoms are absent. Indeed, recent research also suggests prefrontal dysfunction in fully remitted MDD (rMDD). Prefrontal haemodynamic responses may therefore serve as a trait marker for MDD vulnerability.
This study aims to investigate the haemodynamic response in rMDD, healthy participants with increased MDD risk (HCr; having a 1st-degree relative with MDD), and low-risk healthy participants (HCnr; having no 1st-degree relatives with MDD) using fNIRS. The investigators hypothesize lower prefrontal reactivity in HCr compared to HCnr, and lowest prefrontal reactivity in rMDD compared to HCnr.
This study has the potential to elucidate the neuronal underpinnings of depression vulnerability in the absence of symptoms that are sometimes considered a confounding factor when it comes to studying the biological encoding of depression.
Read the detailed description
Healthy participants with a high risk of MDD (HCr), healthy participants with a low risk of MDD (HCnr) and rMDD participants will be included in this study.
Prefrontal haemodynamic response will be measured in all participants during the verbal fluency test (VFT) using 52 channels fNIRS. The VFT involves two neural conditions, one positive condition, and one negative condition.
Both the neuroimage change and the behavioral outcomes of VFT will be compared within-group and among groups. The correlation between the neuroimage change and the behavioral outcomes will be analyzed as well.
- Conditions
- Depression
- Being tested
- fNIRS measurement
- Keywords
- remitted major depression, depression vulnerability
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fNIRS measurementOther
measurement using functional near-infrared spectroscopy
| Study group | Role | What they receive |
|---|---|---|
| Remitted depression | Patients in full remission of a major depressive disorder (rMDD) Receives: Other: fNIRS measurement | |
| Healthy participants at risk | Healthy participants with increased MDD risk (having a 1st-degree relative with MDD) Receives: Other: fNIRS measurement | |
| Healthy participants low risk | Healthy participants with low MDD risk (having no 1st-degree relatives with MDD) Receives: Other: fNIRS measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenated hemoglobin (HbO) change during VFT
The HbO change during VFT measuring by fNIRS
Measured: Up to 6 months
Secondary outcomes (2)
Deoxygenated hemoglobin (HbR) change during VFT
The HbR change during VFT measuring by fNIRS
Measured: Up to 6 months
The VFT outcome
The number of correct words during VFT
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Aug 2021
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Georg Kranz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Georg Kranz, The Hong Kong Polytechnic University
- Investigators
- Georg S Kranz, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427578
- Sponsor's protocol ID
- HSEARS20210323001-01
- Status last verified
- Dec 2024
- First submitted
- 16 Jun 2022
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Markers of Depression Vulnerability: the Case of Prefrontal Haemodynamic Response
- ClinicalTrials.gov ID
- NCT05427578
- Acronym / sponsor ID
- HSEARS20210323001-01
- Conditions
- Depression
- Keywords
- remitted major depression, depression vulnerability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dr Georg KranzUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 22 Jun 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.
Functional near infrared spectroscopy (fNIRS) offers a cheap and reliable tool to investigate prefrontal brain activation in the healthy and diseased human brain. As such, fNIRS bears great potential as a diagnostic tool for clinical practice. Research indicates that fNIRS, together with a relatively simple task to activate the prefrontal cortex, the so-called verbal fluency task (VFT), elucidates prefrontal dysfunction in major depressive disorder (MDD). This finding can potentially serve as an imaging marker for disease pathology, even when depressive symptoms are absent. Indeed, recent research also suggests prefrontal dysfunction in fully remitted MDD (rMDD). Prefrontal haemodynamic responses may therefore serve as a trait marker for MDD vulnerability.
This study aims to investigate the haemodynamic response in rMDD, healthy participants with increased MDD risk (HCr; having a 1st-degree relative with MDD), and low-risk healthy participants (HCnr; having no 1st-degree relatives with MDD) using fNIRS. The investigators hypothesize lower prefrontal reactivity in HCr compared to HCnr, and lowest prefrontal reactivity in rMDD compared to HCnr.
This study has the potential to elucidate the neuronal underpinnings of depression vulnerability in the absence of symptoms that are sometimes considered a confounding factor when it comes to studying the biological encoding of depression.
Detailed description
Healthy participants with a high risk of MDD (HCr), healthy participants with a low risk of MDD (HCnr) and rMDD participants will be included in this study.
Prefrontal haemodynamic response will be measured in all participants during the verbal fluency test (VFT) using 52 channels fNIRS. The VFT involves two neural conditions, one positive condition, and one negative condition.
Both the neuroimage change and the behavioral outcomes of VFT will be compared within-group and among groups. The correlation between the neuroimage change and the behavioral outcomes will be analyzed as well.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remitted depression | – | Other: fNIRS measurementPatients in full remission of a major depressive disorder (rMDD) |
| Healthy participants at risk | – | Other: fNIRS measurementHealthy participants with increased MDD risk (having a 1st-degree relative with MDD) |
| Healthy participants low risk | – | Other: fNIRS measurementHealthy participants with low MDD risk (having no 1st-degree relatives with MDD) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- rMDD group: People who had major depressive disorders now fully remitted HCr group: Healthy control group with a high risk of depression, refer to as healthy volunteers who have a 1st-degree relative with MDD in this study. HCnr group: Healthy control group with a low risk of depression, refer to as healthy volunteers who have no a 1st-degree relative with MDD in this study.
Key inclusion criteria (1 listed)
- Mini-mental state examination (MMSE) > 24
Key exclusion criteria (2 listed)
- Current diagnosis of psychiatric disorders, such as depression, anxiety, schizophrenia, or autism
- current or past diagnosis of neurological disorders, such as head injuries, strokes, encephalitis, epilepsy, Parkinson's, or Alzheimer's
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 |
|---|---|---|
| fNIRS measurementmeasurement using functional near-infrared spectroscopy | Other | Healthy participants at risk, Healthy participants low risk, Remitted depression |
Primary outcome
Oxygenated hemoglobin (HbO) change during VFT
Time frame: Up to 6 months
The HbO change during VFT measuring by fNIRS
2 secondary outcomes
Deoxygenated hemoglobin (HbR) change during VFT
Time frame: Up to 6 months
The VFT outcome
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
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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. This study is not recruiting at the moment.
Georg S Kranz, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Dr Georg Kranz at 1 site in Hong Kong.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 11 Dec 2025. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenated hemoglobin (HbO) change during VFT (time frame: Up to 6 months). 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 11 Dec 2025.