Amygdala-targeted Temporal Interference Stimulation for Major Depressive Disorder。
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
Study Overview
Brief Summary
This randomized, sham-controlled clinical trial aims to evaluate the efficacy and safety of amygdala-targeted transcranial temporal interference stimulation (tTIS) in adults with major depressive disorder (MDD) and to explore its potential neurobiological mechanisms.
The main questions this study aims to answer are:
Whether active amygdala-targeted tTIS reduces depressive symptoms compared with sham stimulation.
Whether tTIS produces changes in amygdala-related neural activity and functional brain networks that are associated with clinical improvement.
Participants will be randomly assigned to receive either active tTIS or sham stimulation. They will complete a course of stimulation sessions and undergo clinical assessments before and after the intervention. Neuroimaging assessments will also be performed to investigate treatment-related changes in the amygdala and associated brain networks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 to 55 years, inclusive, with no restriction on sex.
- •Diagnosed with Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), as determined by a study physician.
- •A 17-item Hamilton Depression Rating Scale (HAMD-17) score ≥17 at screening/baseline.
- •The antidepressant medication regimen must remain stable from at least 30 days before signing the informed consent form through the study period.
- •In the judgment of the investigator, the participant or their legally authorized representative is able to understand the purpose and procedures of the study, comply with the study protocol, and provide written informed consent.
Exclusion Criteria
- •A history of other psychiatric disorders, neurological disorders, or substance abuse that, in the investigator's judgment, may interfere with the assessment of treatment efficacy.
- •A history of epilepsy, seizures, or convulsive episodes.
- •Presence of intracranial metallic foreign bodies or metallic implants in or near the heart.
- •Presence of organic brain disease, or a history of severe head injury or cranial surgery.
- •Receipt of electroconvulsive therapy (ECT) or other physical treatments, such as transcranial magnetic stimulation (TMS), within the 30 days before enrollment.
- •An unstable psychiatric condition or significant suicide risk, as assessed by the investigator.
- •Women who are pregnant or breastfeeding.
- •Current participation in another interventional clinical trial.
- •Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in this study.
Arms & Interventions
Active tTIS
Intervention: Transcranial Temporal Interference Stimulation (Device)
Sham tTIS
Intervention: Sham Transcranial Temporal Interference Stimulation (Device)
Outcomes
Primary Outcomes
Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
Time Frame: Baseline; after 10 stimulation sessions (30 minutes per session; end of Week 2)
The 17-item Hamilton Depression Rating Scale (HAMD-17) is a clinician-rated scale used to assess the severity of depressive symptoms. Total scores range from 0 to 52, with higher scores indicating greater depressive symptom severity. The primary outcome is the change in HAMD-17 total score from baseline to the end of the 10-session intervention.
Secondary Outcomes
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score(Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.)
- Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score Across Treatment and Follow-up(Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.)
- Change in Hamilton Anxiety Rating Scale (HAMA) Total Score(Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.)
- Change in Snaith-Hamilton Pleasure Scale (SHAPS) Score(Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 4 weeks after completion of the 10-session intervention.)
- Change in Pittsburgh Sleep Quality Index (PSQI) Global Score(Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.)
- Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Domain Scores(Baseline,after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 4 weeks after completion of the 10-session intervention.)
- Change in Generalized Anxiety Disorder-7 (GAD-7) Score(Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.)
- Change in Patient Health Questionnaire-9 (PHQ-9) Total Score(Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 1 week and 4 weeks after completion of the 10-session intervention.)
- Change in Cognitive Performance Assessed by the THINC-integrated Tool (THINC-it)(Baseline,after 5 stimulation sessions (30 minutes per session; end of Week 1); after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 4 weeks after completion of the 10-session intervention.)
- Change in Temporal Experience of Pleasure Scale (TEPS) Score(Baseline,after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 4 weeks after completion of the 10-session intervention.)
- Change in Emotion Regulation Questionnaire (ERQ) Score(Baseline,after 10 stimulation sessions (30 minutes per session; end of Week 2); and at 4 weeks after completion of the 10-session intervention.)
Investigators
Jingjing Huang, MD
Chief Physician
Shanghai Pudong New Area Mental Health Center, School of Medicine, Tongji University