Major Depressive Disorder RemissionNCT06402422
Vulnerability Markers for Depression
An observational study of Major Depressive Disorder Remission and Major Depressive Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The current study is a pilot for the GRF project entitled "Predicting illness trajectories in fully remitted major depression using concurrent TBS/fNIRS". The project aims to determine whether immediate prefrontal excitability modulated by intermittent theta-burst stimulation (iTBS) is altered in remitted major… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder Remission, Major Depressive Disorder, Healthy
- What is being tested?
- Theta-burst stimulation
- Type of treatment
- Medical device
- How many people
- 166 participants
- Where
- 1 siteHong Kong
- Study dates
- 8 Oct 2023to 1 Apr 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Four clusters of the population will be recruited, including patients diagnosed with rMDD, currently depressed patients with varying numbers of episodes, healthy subjects, and never-depressed healthy subjects with elevated risk for MDD (defined as having a first-degree relative with a history of depression)
Who may be able to join
- rMDD patients: (a) aged 18 to 65; (b) a clinical diagnosis of recurrent depressive disorder by an experienced psychiatrist but currently in full remission (ICD 11, 6A71.7) according to results of the Mini International Neuropsychiatric Interview (MINI) and the Patient Health Questionnaire (PHQ-9), with a score ≤ 4; (c) at least two previous MDEs within the last 10 years; (d) no or stable (≥4 weeks) psychopharmacological medication.
- Current MDD patients: (a) aged 18 to 65; (b) a clinical diagnosis of current unipolar depressive disorder by an experienced psychiatrist according to DSM-IV; (c) no or stable (≥4 weeks) psychopharmacological medication.
- HCs: (a) aged 18 to 65 and (b) healthiness based on history and psychiatric assessment.
- never-depressed HCs with elevated risk for MDD (HR-HCs): (a) aged 18 to 65, (b) healthiness based on history and psychiatric assessment and (c) with a family history of psychiatric illnesses.
Who cannot join
- rMDD patients: (a) severe internal diseases; (b) neurological disorders or a history of severe head injuries; (c) current psychiatric comorbidities, including addiction; (d) pregnancy; (e) common fNIRS and TMS exclusion criteria, such as a history of brain surgery, head injury, cardiac pacemaker, deep brain stimulation, intracranial metallic particles, history of seizures, and antiepileptics and benzodiazepines corresponding to a dose of >1 mg lorazepam/d.
- MDD patients: (a) severe internal diseases; (b) neurological disorders or a history of severe head injuries; (c) Axis-I disorders and history of alcohol or substance abuse or past co-morbid axis-I disorders being the likely primary cause of the depressive syndrome within the past 6 months; (d) pregnancy; (e) common fNIRS and TMS exclusion criteria, such as a history of brain surgery, head injury, cardiac pacemaker, deep brain stimulation, intracranial metallic particles, history of seizures, and antiepileptics and benzodiazepines corresponding to a dose of >1 mg lorazepam/d.
- HCs: (a) medical history of a major systemic illness or a neurological or psychiatric disorder; (b) psychiatric disorders in their first-degree relatives; (c) pregnancy; and (d) common fNIRS and TMS exclusion criteria as stated above.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vulnerability Markers for Depression: a Concurrent TMS-fNIRS Study
The current study is a pilot for the GRF project entitled "Predicting illness trajectories in fully remitted major depression using concurrent TBS/fNIRS". The project aims to determine whether immediate prefrontal excitability modulated by intermittent theta-burst stimulation (iTBS) is altered in remitted major depressive disorder (rMDD) and therefore classifies as a potential trait marker to predict the incidence of recurrence. In the present cross-sectional study, we will recruit four clusters of population, including patients diagnosed with rMDD, currently depressed patients with varying numbers of episodes, healthy subjects, and never-depressed healthy subjects with elevated risk for MDD (defined as having a first-degree relative with a history of depression), to investigate the relationship between the number of prior episodes, cognitive function, and TBS-induced instantaneous brain activity change in the presumed neuropathological prefrontal cortex (PFC).
- Being tested
- Theta-burst stimulation
- Keywords
- Theta-burst stimulation, Concurrent TBS/fNIRS, Verbal fluency task
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta-burst stimulationDevice
Also called Repetitive transcranial magnetic stimulation (rTMS)
TBS comprises 3-pulse 50-Hz bursts, applied every 200 ms (at 5 Hz). iTBS consists of 2-second trains with an inter-train interval of 8 seconds. The investigators will repeat the trains (30 pulses; 10 bursts) 20 times to reach a total number of 600 pulses (3x10x20). Concurrent iTBS/fNIRS stimulation will be applied over the left DLPFC at an intensity of 90% resting motor threshold (RMT). This corresponds to ~110% of the active motor threshold. Stimulation at 90% RMT will also ensure compliance, reduce sensory discomfort and minimize dropout rates. Still, scalp discomfort will be recorded directly after the stimulation. The stimulation site over the DLPFC will be determined using the international 10-20 system and correspond to the F3 label.
| Study group | Role | What they receive |
|---|---|---|
| rMDD patients | Participants are required to visit the lab twice. In the first visit, participants will first perform a verbal fluency task during which the brain activity will be recorded by fNIRS. Then participants complete a cognitive test called Raven's Advanced Progressive matrices (~ 40 min). In the second visit, participants will receive concurrent iTBS/fNIRS. Receives: Device: Theta-burst stimulation | |
| MDD patients | Participants are required to visit the lab twice. In the first visit, participants will first perform a verbal fluency task during which the brain activity will be recorded by fNIRS. Then participants complete a cognitive test called Raven's Advanced Progressive matrices (~ 40 min). In the second visit, participants will receive concurrent iTBS/fNIRS. Receives: Device: Theta-burst stimulation | |
| Health Controls | Participants are required to visit the lab twice. In the first visit, participants will first perform a verbal fluency task during which the brain activity will be recorded by fNIRS. Then participants complete a cognitive test called Raven's Advanced Progressive matrices (~ 40 min). In the second visit, participants will receive concurrent iTBS/fNIRS. Receives: Device: Theta-burst stimulation | |
| High Risk-HCs | Participants are required to visit the lab twice. In the first visit, participants will first perform a verbal fluency task during which the brain activity will be recorded by fNIRS. Then participants complete a cognitive test called Raven's Advanced Progressive matrices (~ 40 min). In the second visit, participants will receive concurrent iTBS/fNIRS. Receives: Device: Theta-burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxyhemoglobin (HbO) change compared to baseline
Primary imaging outcome measure: iTBS-induced HbO change in the bilater prefrontal cortex during and after stimulation.
Measured: During and within 3 minutes post TBS-fNIRS measurement.
Verbal fluency task induced-oxyhemoglobin (HbO) change compared to baseline
Primary imaging outcome measure: cognitive task-induced HbO change in the bilateral prefrontal cortex.
Measured: During the 60 seconds word-generation blocks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start8 Oct 2023
- Primary completion18 Dec 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder RemissionStudies 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
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal 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
- NCT06402422
- Sponsor's protocol ID
- HSEARS20230705001
- Status last verified
- Dec 2024
- First submitted
- 24 Apr 2024
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: PD may be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vulnerability Markers for Depression: a Concurrent TMS-fNIRS Study
- ClinicalTrials.gov ID
- NCT06402422
- Acronym / sponsor ID
- HSEARS20230705001
- Keywords
- Theta-burst stimulation, Concurrent TBS/fNIRS, Verbal fluency task
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 8 Oct 2023 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 7 May 2024 (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 current study is a pilot for the GRF project entitled "Predicting illness trajectories in fully remitted major depression using concurrent TBS/fNIRS". The project aims to determine whether immediate prefrontal excitability modulated by intermittent theta-burst stimulation (iTBS) is altered in remitted major depressive disorder (rMDD) and therefore classifies as a potential trait marker to predict the incidence of recurrence. In the present cross-sectional study, we will recruit four clusters of population, including patients diagnosed with rMDD, currently depressed patients with varying numbers of episodes, healthy subjects, and never-depressed healthy subjects with elevated risk for MDD (defined as having a first-degree relative with a history of depression), to investigate the relationship between the number of prior episodes, cognitive function, and TBS-induced instantaneous brain activity change in the presumed neuropathological prefrontal cortex (PFC).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| rMDD patients | – | Device: Theta-burst stimulationParticipants are required to visit the lab twice. In the first visit, participants will first perform a verbal fluency task during which the brain activity will be recorded by fNIRS. Then participants complete a cognitive test called Raven's Advanced Progressive matrices (~ 40 min). In the second visit, participants will receive concurrent iTBS/fNIRS. |
| MDD patients | – | Device: Theta-burst stimulationParticipants are required to visit the lab twice. In the first visit, participants will first perform a verbal fluency task during which the brain activity will be recorded by fNIRS. Then participants complete a cognitive test called Raven's Advanced Progressive matrices (~ 40 min). In the second visit, participants will receive concurrent iTBS/fNIRS. |
| Health Controls | – | Device: Theta-burst stimulationParticipants are required to visit the lab twice. In the first visit, participants will first perform a verbal fluency task during which the brain activity will be recorded by fNIRS. Then participants complete a cognitive test called Raven's Advanced Progressive matrices (~ 40 min). In the second visit, participants will receive concurrent iTBS/fNIRS. |
| High Risk-HCs | – | Device: Theta-burst stimulationParticipants are required to visit the lab twice. In the first visit, participants will first perform a verbal fluency task during which the brain activity will be recorded by fNIRS. Then participants complete a cognitive test called Raven's Advanced Progressive matrices (~ 40 min). In the second visit, participants will receive concurrent iTBS/fNIRS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Four clusters of the population will be recruited, including patients diagnosed with rMDD, currently depressed patients with varying numbers of episodes, healthy subjects, and never-depressed healthy subjects with elevated risk for MDD (defined as having a first-degree relative with a history of depression)
Key inclusion criteria (4 listed)
- rMDD patients: (a) aged 18 to 65; (b) a clinical diagnosis of recurrent depressive disorder by an experienced psychiatrist but currently in full remission (ICD 11, 6A71.7) according to results of the Mini International Neuropsychiatric Interview (MINI) and the Patient Health Questionnaire (PHQ-9), with a score ≤ 4; (c) at least two previous MDEs within the last 10 years; (d) no or stable (≥4 weeks) psychopharmacological medication.
- Current MDD patients: (a) aged 18 to 65; (b) a clinical diagnosis of current unipolar depressive disorder by an experienced psychiatrist according to DSM-IV; (c) no or stable (≥4 weeks) psychopharmacological medication.
- HCs: (a) aged 18 to 65 and (b) healthiness based on history and psychiatric assessment.
- never-depressed HCs with elevated risk for MDD (HR-HCs): (a) aged 18 to 65, (b) healthiness based on history and psychiatric assessment and (c) with a family history of psychiatric illnesses.
Key exclusion criteria (3 listed)
- rMDD patients: (a) severe internal diseases; (b) neurological disorders or a history of severe head injuries; (c) current psychiatric comorbidities, including addiction; (d) pregnancy; (e) common fNIRS and TMS exclusion criteria, such as a history of brain surgery, head injury, cardiac pacemaker, deep brain stimulation, intracranial metallic particles, history of seizures, and antiepileptics and benzodiazepines corresponding to a dose of >1 mg lorazepam/d.
- MDD patients: (a) severe internal diseases; (b) neurological disorders or a history of severe head injuries; (c) Axis-I disorders and history of alcohol or substance abuse or past co-morbid axis-I disorders being the likely primary cause of the depressive syndrome within the past 6 months; (d) pregnancy; (e) common fNIRS and TMS exclusion criteria, such as a history of brain surgery, head injury, cardiac pacemaker, deep brain stimulation, intracranial metallic particles, history of seizures, and antiepileptics and benzodiazepines corresponding to a dose of >1 mg lorazepam/d.
- HCs: (a) medical history of a major systemic illness or a neurological or psychiatric disorder; (b) psychiatric disorders in their first-degree relatives; (c) pregnancy; and (d) common fNIRS and TMS exclusion criteria as stated above.
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 |
|---|---|---|
| Theta-burst stimulationAlso: Repetitive transcranial magnetic stimulation (rTMS)TBS comprises 3-pulse 50-Hz bursts, applied every 200 ms (at 5 Hz). iTBS consists of 2-second trains with an inter-train interval of 8 seconds. The investigators will repeat the trains (30 pulses; 10 bursts) 20 times to reach a total number of 600 pulses (3x10x20). Concurrent iTBS/fNIRS stimulation will be applied over the left DLPFC at an intensity of 90% resting motor threshold (RMT). This corresponds to ~110% of the active motor threshold. Stimulation at 90% RMT will also ensure compliance, reduce sensory discomfort and minimize dropout rates. Still, scalp discomfort will be recorded directly after the stimulation. The stimulation site over the DLPFC will be determined using the international 10-20 system and correspond to the F3 label. | Device | Health Controls, High Risk-HCs, MDD patients, rMDD patients |
Primary outcome
Oxyhemoglobin (HbO) change compared to baseline
Time frame: During and within 3 minutes post TBS-fNIRS measurement.
Primary imaging outcome measure: iTBS-induced HbO change in the bilater prefrontal cortex during and after stimulation.
Verbal fluency task induced-oxyhemoglobin (HbO) change compared to baseline
Time frame: During the 60 seconds word-generation blocks.
Primary imaging outcome measure: cognitive task-induced HbO change in the bilateral prefrontal cortex.
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 29 Jun 2025.
- Individual participant dataSharing planned: Yes. PD may be shared upon 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. 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 Major Depressive Disorder Remission and Major Depressive Disorder, run by The Hong Kong Polytechnic University 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 4 inclusion and 3 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 29 Jun 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?
Oxyhemoglobin (HbO) change compared to baseline (time frame: During and within 3 minutes post TBS-fNIRS measurement.). The study lists 2 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 29 Jun 2025.