Depression
Conditions
Keywords
brain stimulation, rTMS
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.
Interventions
DEVICEHigh-frequency rTMS
20 Hz active stimulation, twice daily
DEVICELow-frequency rTMS
1 Hz active stimulation, twice daily
DEVICESham rTMS
Sham stimulation, twice daily
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
(Patient): * 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
(Patient): * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HAM-D17 score | 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
| Measure | Time frame |
|---|---|
| Beck Depression Inventory-II | Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment |
| Beck anxiety inventory | Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Resting-state functional MRI | 1 week pre- and 1 week post-intervention | 10 min resting-state functional MRI acquisition at 3T |
| Electroencephalography | Day 1 and day 15 (final day) of rTMS intervention | 10 min resting-state and task-based (response inhibition, reward sensitivity) acquisitions |
Countries
Canada
Outcome results
None listed