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New treatment option for Major Depression Disorder
Official title Molecular Signatures of TMS Response in Treatment-Resistant Depression
ClinicalTrials.gov ID: NCT07039370
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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:
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ankara, Ankara, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ankara, Ankara, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.