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Treatment Resistant Depression (TRD) / Major Depression / Intermittent Theta Burst Stimulation (iTBS) · Interventional Study
ClinicalTrials.gov · September 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registry entry for a planned single-center study investigating peripheral inflammatory and neuroprotective biomarkers in relation to iTBS response in treatment-resistant depression. The study is currently recruiting and has not yet reported results. No efficacy or biomarker data are available from this registry record.
Interventional, Single Group, Open label, Treatment purpose. Treatment-resistant Depression (TRD), Major Depression; age from 18 Years; to 55 Years; accepts healthy volunteers. Intervention: Active iTBS Treatment. Compared with: Healthy control group (no intervention); no active comparator arm for TRD patients.. n = 100. 2 sites: Turkey (Türkiye).
This is a clinical trial registry entry for a planned single-center study investigating peripheral inflammatory and neuroprotective biomarkers in relation to iTBS response in treatment-resistant depression. The study is currently recruiting and has not yet reported results. No efficacy or biomarker data are available from this registry record.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
No clinical impact can be assessed at this stage. Clinicians should await publication of results to determine whether biomarker profiling predicts iTBS response in TRD or informs personalized treatment selection.
This is a registry record for an ongoing, recruiting interventional study with no results posted; it describes planned design and biomarker measurement in a small single-center sample, but contains no outcome data.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed at this stage. Clinicians should await publication of results to determine whether biomarker profiling predicts iTBS response in TRD or informs personalized treatment selection.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07673913). This is a study registration, not published results. Lead sponsor: Gulhane Training and Research Hospital. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Treatment-resistant Depression (TRD), Major Depression. Interventions: DEVICE: Intermittent Theta Burst Stimulation (iTBS). Primary outcome measures: Change in Hamilton Depression Rating Scale (HAM-D-17) Total Score , Baseline and Week 4. Brief summary: Treatment-resistant depression (TRD) is a major clinical challenge affecting a substantial proportion of patients with major depressive disorder who do not adequately respond to conventional antidepressant treatments. Intermittent theta burst stimulation (iTBS), a non-invasive neuromodulation technique targeting the left dorsolateral prefrontal cortex, has emerged as an effective treatment option for these patients. However, the biological mechanisms underlying treatment response remain poorly understood. This single-center, prospective, investigator-initiated clinical study aims to investigate the effects of iTBS on clinical symptoms, executive functions, and peripheral inflammatory and neuroprotective biomarkers in patients with treatment-resistant depression. Fifty patients with treatment-resistant depression and fifty healthy control participants will be enrolled. Patients will receive active iTBS treatment for four weeks (20 sessions), while healthy controls will undergo baseline clinical, cognitive, and biological assessments without receiving any intervention. Clinical outcomes will be evaluated using the 17-item Hamilton Depression Rating Scale (HAM-D-17), Patient Health Questionnaire-9 (PHQ-9), Clinical Global Impression (CGI), and Insomnia Severity Index (ISI). Executive functions will be assessed using the Wisconsin Card Sorting Test, Trail Making Test A and B, and verbal fluency tests. Peripheral blood samples will be collected before and after treatment to measure inflammatory, neuroplasticity, and neuroprotective biomarkers, including IL-1β, IL-6, IL-10, TNF-α, high-sensitivity C-reactive protein (hs-CRP), brain-derived neurotrophic factor (BDNF), apolipoprotein D (APOD), serum amyloid A1 (SAA1), and serum amyloid A2 (SAA2). Gene expression analyses will also be performed using quantitative polymerase chain reaction (qPCR). The study aims to identify biological mechanisms associated with iTBS treatment response and to explore potential biomarkers that may predict clinical improvement in patients with treatment-resistant depression. The findings may contribute to the development of personalized neuromodulation strategies and biomarker-guided treatment approaches for depression.
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