Establishing a Dose-response Relationship With Accelerated Transcranial Magnetic Stimulation (NCT04243798) | Clinical Trial Compass
CompletedNot Applicable
Establishing a Dose-response Relationship With Accelerated Transcranial Magnetic Stimulation
United States48 participantsStarted 2021-06-15
Plain-language summary
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In a double-blind, randomized, sham-controlled fashion, half the participants will receive accelerated theta-burst stimulation while half will receive sham treatment.
Who can participate
Age range22 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or Female, between the ages of 22 and 65 at the time of screening.
✓. Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information.
✓. Currently diagnosed with Major Depressive Disorder (MDD) and meets criteria for a Major Depressive Episode, according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5).
✓. Medical records confirming a history of moderate to severe treatment-resistance as defined by a score of 7-14 on the Maudsley Staging Method (MSM3).
✓. MADRS score of ≥20 at screening (Visit 1).
✓. TMS naive.
✓. Access to ongoing psychiatric care before and after completion of the study.
✓. Access to clinical rTMS after study completion.
Exclusion criteria
✕. Pregnancy
✕. Primary psychiatric condition other than MDD requiring treatment except stable comorbid anxiety disorder
✕. History of or current psychotic disorder or bipolar disorder
What they're measuring
1
Change in Resting State Functional Connectivity of the Subgenual Anterior Cingulate Cortex (sgACC) and the Default Mode Network (DMN).
Timeframe: Visit 3 (Day 1), Visit 4 (Day 2), Visit 5 (Day 3), Visit 6 (Day 4), Visit 7 (Day 5) and Immediate Post Treatment Follow Up (Visit 8 and Day 6)