NCT07039370Recruiting
Molecular Signatures of TMS Response in Treatment-Resistant Depression
The Relationship Between Plasma Metabolomics and Proteomics Profiling and Response to Transcranial Magnetic Stimulation Therapy in Treatment-Resistant Depression
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 55 (estimated)
- First submitted
- 31 May 2025
- Start date
- Jun 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Gulhane Training and Research Hospital
- Diseases
- Depression
- NCT number
- NCT07039370
What you commit to
- Study type: Interventional
- Planned participants: 55
- From Jun 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of metal implants or foreign bodies incompatible with TMS (e.g., aneurysm clips, surgical clamps, metallic fragments).
Other illness
- History of significant head trauma, loss of consciousness, or intracranial surgery.
- Vitamin deficiencies associated with cognitive impairment (e.g., B12, folate) in pre-TMS labs.
- 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.
- Any serious adverse event or unexpected clinical condition during treatment that necessitates discontinuation of TMS.
Lab values
- Abnormal thyroid hormone levels in pre-TMS laboratory testing.
Other
- Any contraindication to TMS as identified in the standardized pre-TMS risk assessment form.
- Presence of epileptic focus detected on pre-TMS EEG.
- Significantly elevated inflammation markers (e.g., CRP) in pre-TMS bloodwork.
- Electrolyte imbalances on pre-TMS blood testing.
- Voluntary discontinuation of TMS during the treatment course.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gulhane Training and Research Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.