| NCT ID | NCT07603804 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul University - Cerrahpasa |
| Condition | Major Depressive Disorder (MDD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2026-03-08 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2026-03-08 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Cana Aksoy Poyraz, Prof. Dr.
STUDY CHAIR
Istanbul University - Cerrahpasa
Frequently Asked Questions
Who can join the NCT07603804 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Disorder (MDD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07603804 currently recruiting?
Yes, NCT07603804 is actively recruiting participants. Contact the research team at ranaltunel@gmail.com for enrollment information.
Where is the NCT07603804 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07603804 clinical trial?
NCT07603804 is sponsored by Istanbul University - Cerrahpasa. The principal investigator is Cana Aksoy Poyraz, Prof. Dr. at Istanbul University - Cerrahpasa. The trial plans to enroll 35 participants.