Efficacy and Safety of Task-specific, Biomarker-driven, HD-ctACS inTRD.
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About
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 treatment-resistant depression (TRD). The study will enroll 10 patients diagnosed with TRD. Each participant will, in a randomized order, undergo a 4-week active HD-ctACS treatment period and a 4-week sham stimulation (delayed HD-ctACS) period, separated by an 8-week washout period. The primary objective is to assess the efficacy of HD-ctACS in improving core depressive symptoms, with the primary outcome being the difference in the Hamilton Depression Rating Scale (HAMD) total score between the end of the two intervention periods. Secondary objectives include evaluating the safety of the therapy, its effects on other symptom dimensions, and exploring its modulatory effects on neurobiological markers of emotional processing (e.g., NAc gamma power). The total participation time for each subject is approximately 16 weeks.
Enrollment
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Volunteers
Inclusion and exclusion criteria
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
10 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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