Major Depression Clinical Trials

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Investigation of the Relationship Between Changes in Neurobiological Biomarkers After Accelerated Transcranial Magnetic Stimulation Treatment and Treatment Response in Patients With Major Depressive Disorder

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Istanbul University - Cerrahpasa
RECRUITING
Istanbul
Contact Information
Primary
Merve Rana Altunel Ülkü, MD
ranaltunel@gmail.com
+90 506 303 10 68
Time Frame
Start Date: 2026-03-08
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 35
Treatments
Experimental: Accelerated iTBS
Participants receive accelerated bilateral dorsomedial prefrontal cortex intermittent theta burst stimulation (iTBS) administered over five consecutive days, with four sessions per day (20 sessions total). Participants with partial clinical response may receive an additional 10 sessions.
Related Therapeutic Areas
Sponsors
Leads: Istanbul University - Cerrahpasa

This content was sourced from clinicaltrials.gov