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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Accelerated rTMS

    Device

    rTMS targeting will be done using the standard Beam-F3 targeting method. Treatment will be delivered in an accelerated schedule with 50 treatment session over 5 days.

  • Parcel-guided Accelerated rTMS

    Device

    rTMS targeting will be done using brain surface parcellation. Treatment will be delivered in an accelerated schedule with 50 treatment sessions over 5 days.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Standard rTMSActive comparator 1 intervention
Group B: Parcel-guided rTMSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Montgomery-Asberg Depression Rating Scale (MADRS)

Depression severity scale with a score ranging from 0 to 60 where a higher score indicates greater severity of symptoms.

Time frame
Baseline and at end of Week 1

Secondary outcomes

1

Hamilton Depression Rating Scale Anxiety Somatization Subscale (HAMD-AS)

six-item subscale of psychiatric disorder severity where a score is given between 0 and 18 and a higher score indicates greater severity of symptoms

Time frame
Baseline and at Week 1
2

Side-effect form (SEF)

Clinician-rated simple form to document the onset, course, severity, and causality of adverse events

Time frame
Daily from Baseline until Week 1
3

Columbia suicide severity rating scale (C-SSRS)

Rating scale for suicidal ideation with scores ranging from 0 to 5 where a higher score indicates greater severity of symptoms

Time frame
Baseline and Week 1

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Soterix Medical

Lead sponsor

Columbia University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: