Response to Intermittent Theta Burst Stimulation in Treatment-Resistant Depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center study enrolling 50 adults with treatment-resistant depression and 50 healthy controls. Participants with TRD receive active iTBS to the left dorsolateral prefrontal cortex over 20 sessions in four weeks, while controls provide baseline comparisons. The research will assess clinical symptoms, executive function, and peripheral inflammatory and neuroprotective biomarkers to explore mechanisms of response. The trial aims to identify potential biomarkers that correlate with treatment outcomes and to deepen understanding of how iTBS affects neurobiology in TRD. The study is investigator-initiated and conducted at Gulhane Training and Research Hospital in Ankara, Turkey.

Why it matters

Who can join: the full rules

Inclusion Criteria

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.

Exclusion Criteria

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.

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.

Where it's running

• Gulhane Training and Research Hospital
  Ankara, Turkey (Türkiye) Recruiting
• Gulhane Training and Research Hospital
  Ankara, Ankara, Turkey (Türkiye) Not yet recruiting

Study contacts

• Study coordinator: BEYAZIT GARİP, Principal Investigator
• Email: beyazitgarip@gmail.com
• Phone: +903123044512

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.