This is a published study protocol for a single-blind randomized controlled trial. It plans to enroll 56 adults diagnosed with major depressive disorder (MDD) with active suicidal ideation. The study setting is not reported. The intervention is active sequential bilateral dorsolateral prefrontal cortex (DLPFC) accelerated theta-burst stimulation (aTBS), consisting of continuous TBS to the right DLPFC followed by intermittent TBS to the left DLPFC, delivered in 10 weekday sessions with 3600 pulses per session. The comparator is sham stimulation.
The primary outcome is response and remission rates based on the 17-item Hamilton Depression Rating Scale (HAMD-17). Secondary outcomes include the Beck Depression Inventory-II (BDI-II), the Columbia Suicide Severity Rating Scale (C-SSRS), and EEG-derived P300 markers. Assessments are planned immediately after the intervention and at 2-week and 4-week follow-ups. No results are reported, as this is a protocol document.
According to the protocol, safety and tolerability will be evaluated using the Treatment Emergent Symptom Scale (TESS) to record stimulation-related adverse events. Data on adverse events, serious adverse events, and discontinuations are not reported. Key limitations and practice relevance are not discussed in the protocol. Funding and conflicts of interest are not reported. This protocol outlines a planned study; its execution and results are forthcoming.
Researchers have created a detailed plan to study a brain stimulation treatment for adults with major depressive disorder who are experiencing active suicidal thoughts. The study will involve 56 adults. They will receive either real stimulation or a sham (fake) treatment. The real treatment involves applying magnetic pulses to specific areas of the brain over 10 weekday sessions.
The goal is to see if this accelerated form of stimulation can help reduce depression symptoms and suicidal thoughts. Researchers will measure outcomes using standard depression and suicide risk scales, as well as brain activity readings. They plan to check how participants are doing right after treatment and again two and four weeks later.
Safety will be carefully monitored throughout the study using a specific checklist for any side effects related to the stimulation. It is crucial to understand that this document is only a research plan. The actual study has not been conducted, so there are no results on whether the treatment is effective, safe, or tolerable.
Readers should know this is a preliminary step in research. It shows scientists are planning to investigate a potential new approach, but we must wait for the completed study to learn anything meaningful about its benefits or risks for patients.
What this means for you: This is a research plan, not a finished study. We do not know if this brain stimulation treatment works or is safe.
View Original Abstract ↓
IntroductionMajor depressive disorder (MDD) is a prevalent psychiatric condition associated with significant suicide risk. Sequential accelerated theta-burst stimulation (aTBS), which integrates time-efficient stimulation with sequential modulation of multiple targets, represents a promising neuromodulation strategy. However, the efficacy and safety of sequential aTBS in adults with MDD and active suicidal ideation remain unexplored. This study aims to evaluate the therapeutic safety and effect of sequential aTBS on suicidal ideation in adults with MDD, and to explore its associated neurophysiological mechanisms using electroencephalography-derived P300 event-related potentials.Methods and analysisThis study is a single-blind, randomized controlled trial. Fifty-six adults with MDD will be recruited and randomly assigned (1:1) to receive either active sequential bilateral Dorsolateral Prefrontal Cortex (DLPFC) aTBS (10 weekday sessions; 3600 pulses per session) consisting of continuous theta-burst stimulation (cTBS) applied to the right DLPFC followed by intermittent theta-burst stimulation (iTBS) applied to the left DLPFC, or sham stimulation. The primary outcomes will be response and remission rates based on the 17-item Hamilton Depression Rating Scale (HAMD-17). Secondary outcomes will include the Beck Depression Inventory-II (BDI-II), the Columbia Suicide Severity Rating Scale (C-SSRS), and electroencephalography (EEG)-derived electrophysiological markers of cognitive processing (P300). Safety and tolerability will be systematically evaluated throughout the study using the Treatment Emergent Symptom Scale (TESS) to record stimulation-related adverse events. Outcome measures will be assessed at baseline, immediately after the 10-day intervention, and at 2-week and 4-week follow-ups to evaluate the short-term sustainability of treatment effects.DiscussionThe results of this study will provide information regarding the efficacy and safety of sequential aTBS for MDD, evaluating its feasibility and thereby laying a foundation for future clinical interventions and scientific research.Clinical Trial Registrationhttps://www.medicalresearch.org.cn/index, identifier ChiCTR2500109181.
