Parcel-guided rTMS for Major Depressive Disorder
ConditionTreatment Resistant Depression (TRD)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSoterix Medical
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Ever met criteria for a psychotic disorder (Sz, SzAff, Bipolar disorder)
Anorexia nervosa or bulimia nervosa within the last year
Unstable medical condition by history, physical exam or laboratory results
Currently pregnant or breastfeeding women; fecund women not using adequate contraceptive methods or with plan to become pregnant
Trial design
Treatments tested in this trial
- Accelerated rTMS
- Parcel-guided Accelerated rTMS
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Soterix Medical
Lead sponsor
Columbia University
Collaborator
Source ClinicalTrials.gov