Accelerated Intermittent Theta Burst Stimulation (iTBS): Accelerated intermittent theta burst stimulation (iTBS) is administered bilaterally to the dorsomedial prefrontal cortex using a double-cone coil, targeting the stimulation site based on anatomical landmarks. Treatment is delivered over five consecutive days with four sessions per day (total of 20 sessions). Each session consists of 600 pulses per hemisphere (1200 pulses total) at an intensity of 120% of the individual motor threshold. Participants with partial response may receive an additional 10 sessions.
Study summary
Major depressive disorder (MDD) is a common and disabling psychiatric condition, and many patients do not achieve adequate response to standard antidepressant treatments. Accelerated intermittent theta burst stimulation (iTBS) is a promising neuromodulation approach that may provide rapid antidepressant effects. This prospective interventional study aims to evaluate the clinical effectiveness of accelerated bilateral dorsomedial prefrontal cortex iTBS in patients with MDD and to investigate treatment-related changes in neurobiological biomarkers, including cortisol, ACTH, BDNF, IL-1β, IL-6, TNF-α, and CRP. Associations between biomarker changes and treatment response will also be examined.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* Age between 18 and 65 years
* Diagnosis of Major Depressive Disorder according to DSM-5 criteria
* Inadequate response to at least one adequate antidepressant treatment trial
* Hamilton Depression Rating Scale (HAM-D) score ≥14 at baseline
* Stable dose of antidepressant medication for at least 4 weeks prior to study entry
* Ability to provide written informed consent
Exclusion Criteria:
* History of bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic depression
* Current substance use disorder
* Neurological disorders that may affect brain function (e.g., epilepsy, multiple sclerosis, dementia, Parkinson's disease)
* History of epileptic seizures
* Severe head trauma
* Presence of metal implants in the head or neck region
* Cochlear implants
* Cardiac pacemaker or implanted electronic devices
* History of deep brain stimulation or vagus nerve stimulation
* Previous neurosurgical procedures
* Pregnancy or breastfeeding
* Use of medications that may significantly affect neuroendocrine or inflammatory markers (e.g., corticosteroids, immunomodulators)
* Endocrine disorders affecting the hypothalamic-pituitary-adrenal axis (e.g., Cushing's syndrome, Addison's disease, thyroid disorders)
* Autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, Hashimoto thyroiditis)
* Recent surgery or acute infection
* Active suicidal crisis, severe agitation, or inability to comply with study procedures
Primary outcome measure(s)
Change in Hamilton Depression Rating Scale (HAM-D) Score — Baseline, within 3 days after completion of treatment and 1-month follow-up Change in depressive symptom severity measured by the 17-item Hamilton Depression Rating Scale (HAM-D-17). Scores range from 0 to 53, with higher scores indicating greater depression severity.
Trial sites (1)
Facility
City
Region
Status
Istanbul University - Cerrahpasa
Istanbul
Turkey (Türkiye)
Recruiting
More Istanbul University - Cerrahpasa trials in Turkey
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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