Vulnerability Markers for Depression

NCT ID: NCT06402422

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 166 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-08
• Study Completion Date: 2025-04-01

Brief 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 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).

Conditions

Major Depressive Disorder Remission; Major Depressive Disorder; Healthy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Theta-burst stimulation

Intervention Type: DEVICE

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.

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.

Theta-burst stimulation

Intervention Type: DEVICE

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.

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.

Theta-burst stimulation

Intervention Type: DEVICE

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.

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.

Theta-burst stimulation

Intervention Type: DEVICE

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.

Interventions

Theta-burst stimulation

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.

Intervention Type: DEVICE

Other Intervention Names

Repetitive transcranial magnetic stimulation (rTMS)

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr Georg Kranz

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georg S Kranz, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

The Hong Kong Polytechnic University

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

HSEARS20230705001

Identifier Type: -

Identifier Source: org_study_id