Accelerated bilateral DMPFC iTBS for major depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In adults with major depressive disorder who did not respond adequately to at least one antidepressant, the trial delivers accelerated bilateral dorsomedial prefrontal cortex iTBS over five days with four sessions per day (20 sessions total). Participants may receive up to an additional 10 sessions depending on clinical response. Outcomes include changes in depression and anxiety scores and safety, with biomarker analyses (cortisol, ACTH, BDNF, IL-1β, IL-6, TNF-α, CRP) to explore biological correlates of response. Assessments occur at baseline, during treatment, at the end of treatment, and at one-month follow-up. It is a single-arm interventional study sponsored by Istanbul University - Cerrahpasa, conducted in Istanbul.

Why it matters

Who can join: the full rules

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

Where it's running

• Istanbul University - Cerrahpasa
  Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: Merve Rana Altunel Ülkü, MD
• Email: ranaltunel@gmail.com
• Phone: +90 506 303 10 68

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.