Accelerated Transcranial Magnetic Stimulation in Treatment-Resistant Depressed Patients (NCT06783361) | Clinical Trial Compass
CompletedNot Applicable
Accelerated Transcranial Magnetic Stimulation in Treatment-Resistant Depressed Patients
Turkey (Türkiye)50 participantsStarted 2024-11-01
Plain-language summary
Depression is the leading cause of disability worldwide and around 800,000 suicides occur each year. According to the World Health Organization, major depressive disorder (MDD) is expected to be the leading cause of the global burden of disease by 2030. One third of MDD patients do not respond to first-line pharmacologic and psychotherapeutic antidepressant treatments. New antidepressant treatments that are safe, tolerable, fast-acting, durable and effective are needed. Transcranial magnetic stimulation (TMS) is a promising form of non-invasive brain stimulation with rapid antidepressant and suicide prevention effects in MDD. TMS applied to the left dorsolateral prefrontal cortex (DLPFC) is a non-invasive brain stimulation technique approved by the US Food and Drug Administration (FDA) for treatment-resistant depression. TMS involves passing an electric current through a magnetic coil placed on the surface of the scalp, producing a high-intensity magnetic field that travels through the scalp, skull and meninges, stimulating neuronal tissue. This in turn causes changes in functional connectivity. The mechanism of TMS on core depressive symptoms is hypothesized to be mediated in part through indirect inhibitory functional connectivity from the left DLPFC to the subgenual anterior cingulate cortex (sgACC).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 to 65 years old
. Patients diagnosed with Major Depressive Disorder according to DSM 5 and the severity of their illness
. Scoring 7 points or more on the Maudsley staging method
. Having depression unresponsive to 2 different antidepressants
. No clinical mental retardation
. Agree to participate in the study
. Hamilton Depression Rating Scale-17 \[HDRS\] score of 20 or higher
. Montgomery Asberg Depression Rating Scale \[MADRS\] score of 20 or above
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested an 'accelerated' TMS protocol for treatment-resistant depression — meaning multiple sessions per day rather than the usual one — can you explain how that schedule difference might affect both the risks and potential benefits compared to standard TMS?
2The trial used a sham-controlled design, meaning some participants received inactive treatment, and it has now completed — has any results data been published yet, and if so, what did it actually show about depression severity outcomes?
3The trial focused specifically on unipolar major depressive disorder with treatment resistance — given my own diagnosis and treatment history, do I even fit the profile of patients who were studied here?
4Since this trial tested bilateral rTMS (stimulating both sides of the brain), how does that approach differ from the standard one-sided TMS that's already approved, and is there any evidence it's safer or more effective?
5Now that this trial is completed, are there any follow-on studies or similar accelerated TMS protocols actively enrolling that you'd recommend I look into, or would standard TMS or another treatment be a more practical next step for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Diagnosed with a neurological or metabolic disease that affects cognitive functions (Systemic diseases such as diabetes mellitus, cardiovascular disease, cerebrovascular disease, chronic renal failure, Parkinson's disease, multiple sclerosis, polyneuropathy, inflammatory rheumatologic disease and malignancies)
. Having a foreign body such as a pacemaker, intracranial implant that can magnetically interact
. Hearing and visual impairments that prevent communication
. Unstable or acute medical conditions
. Pregnancy or breastfeeding
. Having a primary psychiatric disorder other than major depressive disorder
. Being diagnosed with severe MDD with psychotic features