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
Qualifiers
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
Treatments tested in this trial
- Accelerated Intermittent Theta Burst Stimulation (iTBS)
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov