Clinical trial NCT02702154: High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Major Depression
Official title: A Randomized Sham-Controlled Study of High- and Low-frequency Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: brain stimulation
rTMS
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: HAM-D17 score
timeFrame: Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Secondary outcomes:
measure: Beck Depression Inventory-II
timeFrame: Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
measure: Beck anxiety inventory
timeFrame: Baseline, after each week (10 sessions) of treatment, and 2, 6, and 12 weeks post-treatment
Other outcomes:
measure: Resting-state functional MRI
timeFrame: 1 week pre- and 1 week post-intervention
measure: Electroencephalography
timeFrame: Day 1 and day 15 (final day) of rTMS intervention
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Jonathan Downar, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: