NCT07287839Not yet recruitingPhase 2
Parcel-guided rTMS for Major Depressive Disorder
Phase-2 Trial of Parcel-guided rTMS for Major Depressive Disorder
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
Study comparing standard repetitive transcranial magnetic stimulation (rTMS) for Depression to a novel targeting approach using brain surface parcellation to locate a specific brain target.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 13 Dec 2025
- Start date
- 15 Dec 2025
- Primary completion date
- 1 Jun 2028
- Lead sponsor
- Soterix Medical
- Diseases
- Depression
- NCT number
- NCT07287839
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 15 Dec 2025 to the primary completion date, 1 Jun 2028
- No sites listed in no 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
- Prior non-response to ECT, vagal nerve stimulation (VNS) or deep brain stimulation (DBS)
- For patients on permitted concomitant psychotropic agents (antidepressants, anticonvulsants, benzodiazepines, hypnotics, opiates, triiodothyronine (T3), modafinil, psychostimulants, buspirone, melatonin, omega-3 fatty acids, folate, l-methylfolate, s-adenosyl methionine, lithium) dosing must be stable for at least four weeks prior to study entry and patients must agree to continue at the same dose during the study
Other illness
- Ever met criteria for a psychotic disorder (Sz, SzAff, Bipolar disorder)
- Recent drug or alcohol use disorder with DSM-5 specifier of moderate or severe within 6 months, or mild within 2 months; or lifetime history of IV drug use A- ctively suicidal, as defined by expressive ideation with a plan or with suicidal ideation that requires immediate medical or treatment intervention.
- Neurological or neuromuscular disorder
- Requires medications for a general medical condition that contraindicate the TMS treatment
- History of ketamine treatment within 6 months
- History of monoamine oxidase inhibitor (MAOI) within the past month
- Taking medications that increase the risk of seizures.
Lab values
- Unstable medical condition by history, physical exam or laboratory results
Other
- Anorexia nervosa or bulimia nervosa within the last year
- Currently pregnant or breastfeeding women; fecund women not using adequate contraceptive methods or with plan to become pregnant
- Contraindications to MRI (based on metal screening form)
- Meets criteria for claustrophobia
- Lacks capacity to consent
Who the study is looking for
- DSM-5 diagnosis of major depressive disorder confirmed using the Mini International Neuropsychiatric Interview (MINI30) Axis 1 and mood modules
- Treatment-resistant MDD during the current major depressive episode documented in the MGH Antidepressant Treatment History Questionnaire (ATRQ31), which will be defined as being non-responders (less than 50% of symptom improvement) to two or more depression treatment trials of adequate dose and duration as defined by the MGH ATRQ.
- At least moderate depression severity, operationalized as Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.