Accelerated iTBS for Major Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIstanbul University - Cerrahpasa
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Accelerated Intermittent Theta Burst Stimulation (iTBS)
DeviceAccelerated 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.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Accelerated iTBSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Hamilton Depression Rating Scale (HAM-D) Score
Change in depressive symptom severity measured by the 17-item Hamilton Depression Rating Scale (HAM-D-17). Scores range from 0 to 53, with higher scores indicating greater depression severity.
Time frame
Baseline, within 3 days after completion of treatment and 1-month follow-upSecondary outcomes
1
Treatment Response Rate Based on HAM-D
Proportion of participants achieving ≥50% reduction in HAM-D score from baseline.
Time frame
within 3 days after completion of treatment2
Remission Rate Based on HAM-D
Proportion of participants achieving remission defined as HAM-D score ≤7.
Time frame
Within 3 days after completion of treatment3
Sustained Treatment Response at 1-Month Follow-Up
Proportion of participants maintaining ≥50% reduction in HAM-D score at 1-month follow-up.
Time frame
1 month after treatment completion4
Sustained Remission at 1-Month Follow-Up
Proportion of participants maintaining remission, defined as HAM-D score ≤7, at 1-month follow-up.
Time frame
1 month after treatment completionSponsors and contacts
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Source ClinicalTrials.gov