High-frequency vs. Low-frequency vs. Sham DMPFC-rTMS for Major Depression

University Health Network, Toronto

Status: Unknown

Conditions: Depression

Treatments: Device: High-frequency rTMS; Device: Sham rTMS; Device: Low-frequency rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT02702154

15-9276-A

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups

High-frequency rTMS

Experimental group

Description:

20 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks

Treatment:

Device: High-frequency rTMS

Low-frequency rTMS

Experimental group

Description:

1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks

Treatment:

Device: Low-frequency rTMS

Sham rTMS

Sham Comparator group

Description:

Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks

Treatment:

Device: Sham rTMS