Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of Task-specific, Biomarker-driven, HD-ctACS inTRD.
Lead Sponsor:
Ruijin Hospital
Conditions:
Major Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is a single-center, randomized, double-blind, sham-controlled, crossover exploratory clinical trial designed to evaluate the therapeutic effects of task-specific, biomarker-driven HD-ctACS on tre...
Eligibility Criteria
Inclusion
- Inclusion Criteria Age between 18 and 65 years, any gender.
- Meets DSM-5 diagnostic criteria for Major Depressive Disorder (MDD), currently in a moderate to severe episode (total HAMD score ≥ 17).
- Meets the definition of Treatment-Resistant Depression (TRD): failure to respond to or intolerance of at least two antidepressant medications from different mechanistic classes, administered at an adequate dose and duration (e.g., 6-8 weeks) during the current depressive episode.
- Agrees to maintain a stable dosage of their current antidepressant medication regimen (if taking any) throughout the study period.
- Able to comprehend the study procedures and voluntarily provide written informed consent.
- Has intracranial deep brain electrodes implanted for research purposes, with electrodes located in the target brain regions (e.g., NAc, BNST).
- Exclusion Criteria History of other severe psychiatric disorders such as schizophrenia or bipolar disorder.
- Current severe suicide risk.
- History of alcohol or substance abuse/dependence (within the last year).
- History of epilepsy or has intracranial metal implants (other than the research electrodes).
- Presence of any unstable and significant somatic illness.
- Women who are pregnant or breastfeeding.
- Currently participating in another clinical trial.
Exclusion
Key Trial Info
Start Date :
August 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07184697
Start Date
August 14 2025
End Date
January 1 2026
Last Update
September 22 2025
Active Locations (1)
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1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025