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Accelerated iTBS for Major Depression

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…

ClinicalTrials.gov IDNCT07603804

PhaseNA

Enrollment35

SponsorIstanbul University - Cerrahpasa

Age18 Years – 65 Years

SexALL

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Conditions studied

Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)

About this study

Interventions

Device: 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.

Primary outcomes

Change in Hamilton Depression Rating Scale (HAM-D) Score (Baseline, within 3 days after completion of treatment and 1-month follow-up)

Eligibility information

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

Study locations

Istanbul University - Cerrahpasa, Istanbul, 34000 Turkey (Türkiye)

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-26.