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

Not Applicable

• Conditions: Depression
• Interventions: Device: Low-frequency rTMS; Device: High-frequency rTMS; Device: Sham rTMS

• Registration Number: NCT02702154
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2016-03-02
• Study First Posted: 2016-03-08
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-29
• Last Update Posted: 2018-03-30
• Primary Completion: 2018-04
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-frequency rTMS	Low-frequency rTMS	1 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks
High-frequency rTMS	High-frequency rTMS	20 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks
Sham rTMS	Sham rTMS	Sham repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, twice daily, 5 days per week for 3 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada