Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT07039370

Molecular Signatures of TMS Response in Treatment-Resistant Depression

Led by Gulhane Training and Research Hospital · Updated on 2025-06-26

55

Participants Needed

2

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Transcranial Magnetic Stimulation (TMS) therapy is an approved and effective treatment option for treatment-resistant depression (TRD). This study aims to identify biomarkers that predict TMS treatment response in TRD, provide insights into the neurobiological mechanisms underlying TMS efficacy, and contribute to personalized treatment strategies. By establishing proteomic and metabolomic signatures, this research seeks to enhance clinical decision-making, reduce healthcare costs, and improve patient outcomes in TRD. The findings will align with the precision medicine movement in psychiatry, advancing biomarker-driven therapeutic approaches for treatment-resistant depression.

CONDITIONS

Official Title

Molecular Signatures of TMS Response in Treatment-Resistant Depression

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Major Depressive Disorder (MDD) according to DSM-5-TR criteria
  • Inadequate response to at least two antidepressants or anti-obsessive agents at therapeutic doses and durations
  • Symptoms not better explained by metabolic or organic medical conditions
  • No epileptic activity on routine EEG before starting TMS
  • Normal thyroid hormone levels and no significant vitamin deficiencies or elevated inflammatory markers in pre-TMS lab tests
  • No history or evidence of hearing loss, or evaluated by an otolaryngologist if present
  • Age 18 years or older
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Any contraindications to TMS identified in the pre-TMS risk assessment
  • Epileptic focus detected on pre-TMS EEG
  • History of significant head trauma, loss of consciousness, or brain 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 labs
  • Elevated inflammatory markers (e.g., CRP) in pre-TMS bloodwork
  • Vitamin deficiencies linked to cognitive impairment (e.g., B12, folate) in pre-TMS labs
  • Electrolyte imbalances in 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 unless abstinent for at least 12 months (excluding alcohol)
  • Voluntary discontinuation of TMS during treatment
  • Serious adverse events or unexpected clinical conditions requiring TMS discontinuation

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Gulhane Training and Research Hospital

Ankara, Ankara, Turkey (Türkiye), 06000

Actively Recruiting

2

Gulhane Training and Research Hospital

Ankara, Ankara, Turkey (Türkiye), 06300

Actively Recruiting

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Research Team

B

BEYAZIT GARİP, Medical Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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