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RECRUITING

NCT07039370

Molecular Signatures of TMS Response in Treatment-Resistant Depression

Sponsor: Gulhane Training and Research Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: The Relationship Between Plasma Metabolomics and Proteomics Profiling and Response to Transcranial Magnetic Stimulation Therapy in Treatment-Resistant Depression

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-15

Completion Date

2027-06-01

Last Updated

2025-06-26

Healthy Volunteers

Yes

Conditions

Major Depression Disorder

Interventions

DEVICE

TMS

Transcranial Magnetic Stimulation (TMS) is a non-invasive brain stimulation technique approved for the treatment of major depressive disorder (MDD), particularly in individuals with treatment-resistant depression (TRD). TMS targets the left dorsolateral prefrontal cortex (DLPFC), a brain region often underactive in depression, and modulates neural activity through magnetic pulses. This study aims to evaluate the effects of TMS on plasma proteomic and metabolomic profiles in patients with TRD. Participants will undergo 20 sessions of intermittent theta burst stimulation (iTBS) over four weeks. Blood samples will be collected before and after treatment to identify molecular changes associated with clinical response. Healthy controls will provide single-time-point blood samples for baseline comparison. Findings may support the development of biomarker-based strategies for personalized treatment in psychiatry.

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.

Locations (2)

Gulhane Training and Research Hospital

Ankara, Ankara, Turkey (Türkiye)