Blood markers that predict TMS response 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 cohort study enrolling 55 adults with treatment-resistant major depressive disorder and 55 age- and sex-matched healthy controls. Patients will receive a standardized TMS protocol of 20 intermittent theta burst stimulation (iTBS) sessions over four weeks targeting the left dorsolateral prefrontal cortex, with motor threshold calibrated weekly. Plasma samples will be collected before the first TMS session and after the 20th session for proteomic and metabolomic profiling, and profiles will be compared to clinical treatment response. The goal is to identify blood-based molecular signatures that predict or reflect clinical benefit from TMS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of Major Depressive Disorder (MDD) according to DSM-5-TR criteria.
* Inadequate clinical response to at least two different antidepressants and/or anti-obsessive agents administered at therapeutic doses and durations.
* Clinical symptoms not better explained by metabolic or organic medical conditions.
* No epileptic activity detected on routine electroencephalography (EEG) prior to TMS initiation.
* Routine pre-TMS laboratory tests reveal no abnormalities that may significantly affect treatment response, including:
* Normal thyroid hormone profile
* No significant vitamin deficiencies
* No markedly elevated inflammatory markers
* No history or current evidence of hearing loss on clinical evaluation; if present, evaluation by an otolaryngologist will be obtained.
* Age 18 years and older.
* Ability to provide written informed consent.

Exclusion Criteria:

* Any contraindication to TMS as identified in the standardized pre-TMS risk assessment form.
* Presence of epileptic focus detected on pre-TMS EEG.
* History of significant head trauma, loss of consciousness, or intracranial surgery.
* Presence of metal implants or foreign bodies incompatible with TMS (e.g., aneurysm clips, surgical clamps, metallic fragments).
* Abnormal thyroid hormone levels in pre-TMS laboratory testing.
* Significantly elevated inflammation markers (e.g., CRP) in pre-TMS bloodwork.
* Vitamin deficiencies associated with cognitive impairment (e.g., B12, folate) in pre-TMS labs.
* Electrolyte imbalances on pre-TMS blood testing.
* History of psychotic disorder or bipolar I/II disorder.
* History of substance-induced psychosis or bipolar disorder.
* Current or past substance use disorder (including alcohol, stimulants, or illicit drugs), unless abstinent from substances (excluding alcohol) for a minimum of 12 months.
* Voluntary discontinuation of TMS during the treatment course.
* Any serious adverse event or unexpected clinical condition during treatment that necessitates discontinuation of TMS.

Where it's running

• Gulhane Training and Research Hospital
  Ankara, Ankara, Turkey (Türkiye) Recruiting
• Gulhane Training and Research Hospital
  Ankara, Ankara, Turkey (Türkiye) Recruiting

Study contacts

• Study coordinator: BEYAZIT GARİP, Medical Doctor
• 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.