High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Major Depression
NCT ID: NCT02702154
Last Updated: 2018-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2016-02-29
2018-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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High-frequency rTMS
20 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks
High-frequency rTMS
20 Hz active stimulation, twice daily
Low-frequency rTMS
1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks
Low-frequency rTMS
1 Hz active stimulation, twice daily
Sham rTMS
Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks
Sham rTMS
Sham stimulation, twice daily
Interventions
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High-frequency rTMS
20 Hz active stimulation, twice daily
Low-frequency rTMS
1 Hz active stimulation, twice daily
Sham rTMS
Sham stimulation, twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Jonathan Downar
Co-Director, UHN MRI-Guided rTMS Clinic
Principal Investigators
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Jonathan Downar, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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Toronto Western Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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15-9276-A
Identifier Type: -
Identifier Source: org_study_id
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