Vulnerability Markers for Depression

NCT06402422 | Completed

• 1 other identifier: HSEARS20230705001
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 1

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

Keywords

Theta-burst stimulation; Concurrent TBS/fNIRS; Verbal fluency task

Outcome Measures

Primary Outcomes (2)

• Oxyhemoglobin (HbO) change compared to baseline

  Primary imaging outcome measure: iTBS-induced HbO change in the bilater prefrontal cortex during and after stimulation.

  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.

  During the 60 seconds word-generation blocks.

Study Arms (4)

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.

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.

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.

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.

Device: Theta-burst stimulation

Interventions

Theta-burst stimulation 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.

Also known as: Repetitive transcranial magnetic stimulation (rTMS)

Health Controls; High Risk-HCs; MDD patients; rMDD patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Georg S Kranz, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 7, 2024
• Study Start: October 8, 2023
• Primary Completion: December 18, 2024
• Study Completion: April 1, 2025
• Last Updated: June 29, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Upon request
• Access Criteria: Upon request

Locations

HK (1)