Actively Recruiting
Intermittent Theta-burst Stimulation for Major Depression: an Intensity-response Study
Led by The Hong Kong Polytechnic University · Updated on 2025-03-14
246
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
T
The Hong Kong Polytechnic University
Lead Sponsor
H
Health and Medical Research Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of intermittent theta-burst stimulation (iTBS), a form of repetitive transcranial magnetic stimulation approved by the FDA in 2018, to treat major depressive disorder (MDD). This study focuses on comparing the antidepressant effects of iTBS at different stimulation intensities: 75% and 120% of the resting motor threshold (rMT), against a sham control. The goal is to determine whether lower stimulation intensities can provide effective treatment with less discomfort and better adherence compared to the currently standard 120% rMT intensity. Participants will be randomly assigned to one of three groups: sham iTBS (inactive coil side), iTBS at 75% rMT, or iTBS at 120% rMT. Each group will receive 20 daily sessions over four weeks, Monday through Friday. Treatments will be delivered using a MagPro X100 device with a Cool-B65 A/P Butterfly Coil, targeting the left dorsolateral prefrontal cortex (DLPFC) based on EEG positioning. The study is conducted at the brain stimulation laboratory of the Hong Kong Polytechnic University. During the study, participants will undergo assessments including the Montgomery-Asberg Depression Rating Scale (MADRS), Patient Health Questionnaire-9 (PHQ-9), Subjective Happiness Scale (SHS), and pain level ratings, all measured over the one-month treatment period. Researchers will monitor depressive symptoms, mood, happiness, and treatment tolerability. The study aims to evaluate the clinical benefits and side effects related to different stimulation intensities and improve treatment adherence for patients with MDD.
CONDITIONS
Brief Title
Intermittent Theta-burst Stimulation for Major Depression: an Intensity-response Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 70 years
- Diagnosed with major depressive disorder (single or recurrent episode) according to DSM-5 and confirmed by MINI
- Current episode with a score of at least 18 on the 17-item Hamilton Rating Scale for Depression (HDRS17)
- Have not responded to two or more standard antidepressant treatments during current episode
- Stable psychopharmacological treatment for at least 4 weeks before screening
- Normal thyroid function, complete blood count, electrolytes, and liver enzyme levels based on pre-study blood work
You will not qualify if you...
- History of substance abuse or dependence in the past 3 months
- Major unstable medical illness, cardiac pacemaker, or implanted medication pump
- Active suicidal intent with MADRS item 10 score greater than 4
- Pregnant
- Lifetime diagnosis of bipolar I or II, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms
- Metal implants or other MRI/TMS exclusion criteria
- Taking antiepileptic drugs or benzodiazepines above 1 mg lorazepam per day
- Recent changes in psychotropic medication within 4 weeks prior to screening
- Previous treatment with transcranial magnetic stimulation (TMS) therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive daily intermittent theta-burst stimulation (iTBS) treatments targeting major depressive disorder at one of three intensity levels: 75%, 120% of the resting motor threshold, or sham stimulation. Treatments occur on weekdays over four weeks.
20 visits (in-person, Monday to Friday)
Trial Site Locations
Total: 1 location
1
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Actively Recruiting
Research Team
G
Georg Kranz, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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