Actively Recruiting
Investigation of Neurobiological Biomarker Changes After Accelerated Transcranial Magnetic Stimulation Treatment and Response in Major Depressive Disorder
Led by Istanbul University - Cerrahpasa · Updated on 2026-05-22
35
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Major depressive disorder (MDD) is a common and disabling psychiatric condition that often does not respond well to standard antidepressant treatments. This research aims to evaluate the effectiveness of accelerated bilateral dorsomedial prefrontal cortex intermittent theta burst stimulation (iTBS) in adults with MDD who have had an inadequate response to at least one antidepressant trial. The study also investigates changes in neurobiological biomarkers such as cortisol, ACTH, BDNF, inflammatory markers, and their relationship with treatment response. Participants aged 18 to 65 will receive accelerated bilateral DMPFC iTBS delivered using a double-cone coil over five consecutive days with four sessions each day, totaling 20 sessions. Each session delivers 1200 pulses at 120% of the motor threshold. Those showing partial improvement without remission after these sessions may receive an additional 10 sessions according to clinical assessment. During the study, clinical assessments will be conducted at baseline, during treatment, after treatment completion, and at one-month follow-up. These include depression and anxiety rating scales, suicidal ideation measures, and global impression ratings. Blood samples will be collected to measure various biomarkers before and after treatment. The main outcome measured is the change in depression severity on the Hamilton Depression Rating Scale (HAM-D). Safety and symptom monitoring will continue throughout the study period.
CONDITIONS
Brief Title
Accelerated iTBS for Major Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 64 at baseline
- Stable dose of antidepressant medication for at least 4 weeks prior to study entry
- Ability to provide written informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 consecutive days, with possible extension for additional sessions
Participants receive accelerated bilateral dorsomedial prefrontal cortex intermittent theta burst stimulation (iTBS) over five consecutive days, with four sessions per day (20 sessions total). Participants with partial clinical response may receive an additional 10 sessions.
Multiple visits daily for 5 days
Duration - 1 month after treatment completion
Participants are monitored for clinical and biomarker changes at one month after treatment completion.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Istanbul University - Cerrahpasa
Istanbul, Turkey (Türkiye), 34000
Actively Recruiting
Research Team
M
Merve Rana Altunel Ülkü, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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