A Randomized Sham-Controlled Study of High- and Low-frequency Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex in Major Depressive Disorder
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- HAM-D17 score
Study Overview
Brief Summary
This trial will compare the efficacy and tolerability of 20 Hz vs. 1 Hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered twice daily over 15 days, in patients with a diagnosis of major depressive disorder. The trial will include structural and functional MRI, EEG, and behavioral measures obtained before, during, and after treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Voluntary and competent to consent to treatment
- •MINI confirmed diagnosis of MDD
- •Outpatient
- •Between the ages of 18-65
- •Failed to achieve a clinical response to at least one pharmacotherapy or behavioral treatment in the current episode.
- •Have had no increase or initiation of any psychotropic medication in the last 4 weeks prior to screening
- •Must adhere to study assessment and intervention schedule.
- •Pass the TMS Safety Screening Questionnaire.
Exclusion Criteria
- •Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medical pump
- •Have active suicidal intent
- •Are pregnant
- •Have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms have a MINI diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than MDD
- •Have received rTMS for any previous indication due to the potential compromise of subject blinding.
Arms & Interventions
High-frequency rTMS
20 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks
Intervention: High-frequency rTMS (Device)
Low-frequency rTMS
1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks
Intervention: Low-frequency rTMS (Device)
Sham rTMS
Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks
Intervention: Sham rTMS (Device)
Outcomes
Primary Outcomes
HAM-D17 score
Time Frame: Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Outcome measured by a change in HAM-D17 score from baseline to 2 weeks post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of \<8 is categorized as remission.
Secondary Outcomes
- Beck anxiety inventory(Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment)
- Beck Depression Inventory-II(Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment)
Investigators
Jonathan Downar
Co-Director, UHN MRI-Guided rTMS Clinic
University Health Network, Toronto