Accelerated iTBS for Major Depression

Recruiting now · Not applicable

Conditions studied: Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)

In brief

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.

Key facts

Study ID

NCT07603804

Run by

Istanbul University - Cerrahpasa

People needed

35

Starts

2026-03-08

Expected to finish

2026-12-31

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Istanbul University - Cerrahpasa — Istanbul, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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