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Depression · Interventional Study
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned interventional study registration examining whether 10 Hz rTMS to the left dorsolateral prefrontal cortex normalizes dopaminergic frontostriatal circuit function and improves both mood and metabolic markers in patients with depression and comorbid metabolic disorder. No results are posted; the study remains active but not recruiting.
Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Depression; age from 20 Years; to 70 Years. Intervention: MDD patient with HRSD score of at least 18; BD patient with HRSD score of at least 18. n = 90. 1 site: Taiwan.
This is a planned interventional study registration examining whether 10 Hz rTMS to the left dorsolateral prefrontal cortex normalizes dopaminergic frontostriatal circuit function and improves both mood and metabolic markers in patients with depression and comorbid metabolic disorder. No results are posted; the study remains active but not recruiting.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This trial may provide mechanistic insights into the link between dopaminergic dysregulation and co-occurrence of depression with metabolic disorder, and could inform development of personalized non-invasive brain stimulation treatment. However, no clinical benefit has been demonstrated; the study is still enrolling and no results are available.
This is a study registration with no posted results; it describes a planned interventional trial testing rTMS in depression with metabolic comorbidity, enrolling 90 participants over 3 months with multiple neuroimaging and metabolic endpoints.
As stated by the source record.
Quoted from the source exactly as published.
This trial may provide mechanistic insights into the link between dopaminergic dysregulation and co-occurrence of depression with metabolic disorder, and could inform development of personalized non-invasive brain stimulation treatment. However, no clinical benefit has been demonstrated; the study is still enrolling and no results are available.
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 (NCT05117983). This is a study registration, not published results. Lead sponsor: National Cheng-Kung University Hospital. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 90 participants (ESTIMATED). Conditions: Depression. Interventions: DEVICE: Repetitive transcranial magnetic stimulation (rTMS). Primary outcome measures: Change from baseline mood symptom severity at several timepoints over 3 months , Week 0, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12.; Iowa gambling task (IGT) with functional MR imaging , Week 0; Change from baseline functional connectivity maps at 3 months , Week 0, Week 12; Change from baseline homeostasis model assessment-estimated insulin resistance (HOMA-IR) index at several timepoints within 3 months , Week 0, Week 4, Week 8, Week 12; Change from baseline body mass index (BMI) at several timepoints within 3 months , Week 0, Week 4, Week 8, Week 12; Change from baseline waist and hip circumference at several timepoints within 3 months , Week 0, Week 4, Week 8, Week 12; Change from baseline fasting serum leptin level at several timepoints within 3 months , Week 0, Week 4, Week 8, Week 12; Change from baseline fasting serum lipid level at several timepoints within 3 months , Week 0, Week 4, Week 8, Week 12; Change from baseline immunological markers at several timepoints within 3 months , Week 0, Week 2, Week 3, Week 4, Week 8, Week 12; Change from baseline neurocognitive performance at 3 months , Week 0, Week 12; Change from baseline social cognitive function at 3 months , Week 0, Week 12; Change from baseline autonomic nervous system performance at several timepoints within 3 months , Week 0, Week 4, Week 12. Brief summary: Depression and metabolic disorder (MetD) are two of the most common and debilitating disorders worldwide, occurring with significant rates of comorbidity. This is a major clinical challenge as the outcomes of both conditions are worsened. Studies have uncovered that depression and metabolic disorder are associated with chronic, low-grade inflammation. In brain circuit level, patients with depression are characterized with aberrant frontostriatal (FS) circuit connectivity and reduced activity level that also associated with metabolic comorbidity. In neurotransmitter level, the dopaminergic pathway, that could be feedback regulated by immune and metabolic factors, has long been known to involve in emotional and metabolic homeostasis. More importantly, this dopamine (DA) input is critical to shaping the FS circuit-level dynamic connectivity and plasticity. Therefore, this study hypothesizes that inflammatory and metabolic dysregulations on DA transmission link to the aberrant FS function that cause mood and metabolic syndromes. To clarify the underlying mechanisms, 90 patients who meet the DSM-5 diagnostic criteria of major depressive episode in either major depressive disorder or bipolar disorder are planned to be recruit. FS functional connectivity and activation, before and after receiving 10 Hz repetitive transcranial magnetic stimulation (rTMS) to left dorsolateral prefrontal cortex will be measured. Then systemically analyze participants' clinical symptomology, neurocognitive function, inflammation and metabolic status. Possible correlations between indices, the effects of rTMS and differences between groups will be tested. Results could provide a chance for further understanding the pathophysiology of depression with MetD and comparing between unipolar and bipolar depression, and developing brain circuit based non-invasive brain stimulation personalized treatment for depression with MetD to achieve a better outcome.
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