Actively Recruiting
Relationship Between Plasma Metabolomics and Proteomics Profiles and Response to Transcranial Magnetic Stimulation Therapy in Treatment-Resistant Depression
Led by Gulhane Training and Research Hospital · Updated on 2025-06-26
55
Participants Needed
2
Research Sites
24 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how blood-based molecular markers in plasma, including proteins and metabolites, relate to response to transcranial magnetic stimulation (TMS) therapy in adults with treatment-resistant depression (TRD). TRD is a form of major depressive disorder that does not improve after trying at least two antidepressant medications. This study aims to identify biological signatures that predict who will benefit from TMS, helping to personalize treatment and improve outcomes while reducing healthcare costs. Participants diagnosed with TRD will receive TMS using the MagVenture X100 device, targeting the left dorsolateral prefrontal cortex with intermittent theta burst stimulation. Treatment consists of 20 sessions over four weeks, five sessions per week. Motor thresholds will be measured weekly to adjust stimulation intensity to 90% of resting motor threshold. Blood samples will be taken before the first session and after the last session to analyze proteomic and metabolomic changes. A matched group of healthy individuals will provide blood samples once for baseline comparison. Participants will undergo psychiatric assessments including depression severity scales and sleep quality questionnaires before and after treatment. Advanced laboratory analyses will identify molecular differences linked to treatment response. Researchers will track changes in depression scores, side effects, and correlations with medication history. The study will last four weeks per participant, focusing on understanding the biological basis of TMS response to support more tailored treatments for TRD.
CONDITIONS
Brief Title
Molecular Signatures of TMS Response in Treatment-Resistant Depression
Who Can Participate
Eligibility Criteria
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
- Clinical symptoms not explained better by metabolic or organic medical conditions
- No epileptic activity detected on routine EEG before starting TMS
- Normal thyroid hormone profile and no significant vitamin deficiencies or elevated inflammatory markers
- No history or current evidence of hearing loss, or evaluation by an otolaryngologist if present
- Age 18 years or older
- Ability to provide written informed consent
You will not qualify if you...
- Any contraindications to TMS identified by standardized risk assessment
- Presence of epileptic focus 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 or significantly elevated inflammation markers
- Vitamin deficiencies affecting cognition (e.g., B12, folate)
- Electrolyte imbalances on pre-TMS 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 (excluding alcohol) for at least 12 months
- Voluntary discontinuation of TMS during treatment
- Serious adverse event or unexpected clinical condition requiring TMS discontinuation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants diagnosed with treatment-resistant depression undergo 20 sessions of transcranial magnetic stimulation (TMS) over four weeks using a non-invasive brain stimulation device targeting the left dorsolateral prefrontal cortex. Motor threshold is assessed weekly to adjust treatment intensity.
20 treatment sessions (in-person) over 4 weeks, 5 sessions per week
Duration - 4 weeks (concurrent with treatment)
Blood samples and psychiatric assessments are conducted before the first and after the 20th TMS session to evaluate molecular changes and clinical response.
2 visits for blood collection and assessments (pre-treatment and post-treatment)
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
Research Team
B
BEYAZIT GARİP, Medical Doctor
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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