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Magnetic brain stimulation and blood markers in treatment-resistant depression

Studies how theta burst stimulation relates to blood markers in treatment-resistant depression.

Key facts

Who runs it
Gulhane Training and Research Hospital
Where
Ankara, TürkiyeSee the site
Trial code
Registry title
Relationship of Peripheral Inflammatory and Neuroprotective Biomarkers With Response to Intermittent Theta Burst Stimulation in Treatment-Resistant Depression
Status
Recruiting
People taking part
100 people, planned
Started
1 Sept 2026
Expected to end
1 Sept 2027
Type of study
Interventional
Treatments tested
  • Intermittent Theta Burst Stimulation (iTBS)
Record updated
14 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with treatment-resistant depression who can have magnetic brain stimulation (iTBS), and for healthy adults as a comparison group.

Age
18 to 55 years
Sex
Men and women
Disease stage
Major depressive disorder (DSM-5-TR) that has not improved enough with at least two antidepressant treatments at adequate doses and durations.
Earlier treatment
At least two antidepressant treatments that did not work well enough. No electroconvulsive therapy, deep brain stimulation or vagus nerve stimulation in the previous 5 years. No earlier intravenous or intranasal ketamine treatment.

Main reasons for not taking part

  • Schizophrenia, bipolar disorder or other major psychiatric disorders
  • Epilepsy, brain tumor, severe head injury or significant neurological disease
  • Metal implants in the head, pacemaker, cochlear implant or other incompatible implanted devices
  • Active infection, autoimmune disease or chronic inflammatory disease
  • Pregnancy or breastfeeding; active alcohol or substance use disorder

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Treatment-Resistant Depression Group:
  • Age between 18 and 55 years. Male or female participants. Diagnosis of Major Depressive Disorder according to DSM-5-TR criteria. Inadequate response to at least two antidepressant treatments administered at adequate doses and durations
  • Eligible for transcranial magnetic stimulation (TMS) treatment. Able and willing to provide written informed consent. Able to complete neuropsychological assessments. Able to attend study visits and complete the treatment protocol
  • Healthy Control Group:
  • Age between 18 and 55 years. Male or female participants. No current DSM-5-TR psychiatric disorder. Able and willing to provide written informed consent. Able to complete neuropsychological assessments

Who cannot take part

  • Active infection. Autoimmune disease or chronic inflammatory disease. Electroconvulsive therapy, deep brain stimulation, or vagus nerve stimulation within the previous 5 years
  • Previous intravenous or intranasal ketamine treatment. Pregnancy or breastfeeding. Active alcohol or substance use disorder. Inability to comply with study procedures. Inability to tolerate the iTBS protocol. Withdrawal of informed consent at any stage of the study
  • Schizophrenia, bipolar disorder, organic mental disorders, or other major psychiatric disorders
  • History of epilepsy, brain tumor, severe head trauma, or significant neurological disease
  • Any contraindication to TMS. Presence of intracranial metal implants, cardiac pacemakers, cochlear implants, or other incompatible implanted devices

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 55 years old?

Where in Türkiye

  • Gulhane Training and Research HospitalAnkara, TürkiyeContact: BEYAZIT GARİP, Principal InvestigatorNot yet recruiting

About the trial

What the trial wants to find out

Treatment-resistant depression (TRD) is a major clinical challenge affecting a substantial proportion of patients with major depressive disorder who do not adequately respond to conventional antidepressant treatments. Intermittent theta burst stimulation (iTBS), a non-invasive neuromodulation technique targeting the left dorsolateral prefrontal cortex, has emerged as an effective treatment option for these patients. However, the biological mechanisms underlying treatment response remain poorly understood.

Read full original descriptionShow less

This single-center, prospective, investigator-initiated clinical study aims to investigate the effects of iTBS on clinical symptoms, executive functions, and peripheral inflammatory and neuroprotective biomarkers in patients with treatment-resistant depression.

Fifty patients with treatment-resistant depression and fifty healthy control participants will be enrolled. Patients will receive active iTBS treatment for four weeks (20 sessions), while healthy controls will undergo baseline clinical, cognitive, and biological assessments without receiving any intervention.

Clinical outcomes will be evaluated using the 17-item Hamilton Depression Rating Scale (HAM-D-17), Patient Health Questionnaire-9 (PHQ-9), Clinical Global Impression (CGI), and Insomnia Severity Index (ISI). Executive functions will be assessed using the Wisconsin Card Sorting Test, Trail Making Test A and B, and verbal fluency tests.

Peripheral blood samples will be collected before and after treatment to measure inflammatory, neuroplasticity, and neuroprotective biomarkers, including IL-1β, IL-6, IL-10, TNF-α, high-sensitivity C-reactive protein (hs-CRP), brain-derived neurotrophic factor (BDNF), apolipoprotein D (APOD), serum amyloid A1 (SAA1), and serum amyloid A2 (SAA2). Gene expression analyses will also be performed using quantitative polymerase chain reaction (qPCR).

The study aims to identify biological mechanisms associated with iTBS treatment response and to explore potential biomarkers that may predict clinical improvement in patients with treatment-resistant depression. The findings may contribute to the development of personalized neuromodulation strategies and biomarker-guided treatment approaches for depression.

The group in the trial

  • Active iTBS TreatmentTreatment being tested

    Participants with treatment-resistant depression will receive active intermittent theta burst stimulation (iTBS) over the left dorsolateral prefrontal cortex using a MagVenture X100 device. Treatment will be administered at 90% of the resting motor threshold, with 1800 pulses per session, 5 sessions per week, for a total of 20 sessions over 4 weeks. Participants will continue their routine pharmacological treatments throughout the study. Clinical assessments, neuropsychological testing, and peripheral biomarker analyses will be performed before and after treatment.

    Treatment: Intermittent Theta Burst Stimulation (iTBS)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Relationship Between Response to Transcranial Magnetic Stimulation and Peripheral Inflammatory and Neuroprotective Biomarkers in Patients With Treatment-Resistant Depression
Plain-language title
Magnetic brain stimulation and blood markers in treatment-resistant depressionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07673913, who can take part
Record updated
14 September 2026