Comparing Different Patterns of rTMS in Major Depression

Not Applicable

• Conditions: Depression; Bipolar Disorder
• Interventions: Device: Dorsomedial prefrontal rTMS

• Registration Number: NCT02778035
• Lead Sponsor: University Health Network, Toronto

Brief Summary

This trial will compare the trajectories of improvement for three different patterns of twice-daily rTMS in major depression: two daily sessions of dorsomedial prefrontal rTMS delivered at 0 min vs. 30 min vs. 60 min intervals.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-19
• Status Verified: 2018-02
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-14
• Primary Completion: 2019-03
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
30 min inter-session interval	Dorsomedial prefrontal rTMS	Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 30 min).
60 min inter-session interval	Dorsomedial prefrontal rTMS	Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 60 min).
0 min inter-session interval	Dorsomedial prefrontal rTMS	Repetitive transcranial magnetic stimulation (rTMS) to bilateral dorsomedial prefrontal cortex, twice daily, 5 days per week for 4 weeks (Inter-session interval, 0 min).

Primary Outcome Measures

Name	Time	Method
17-Item Hamilton Rating Scale for Depression (HAMD-17)	Baseline, after each week of treatment (i.e. after 5 days of treatment), and 1, 4, and 12 weeks post-treatment. Treatment will include 5 daily weekday visits over 4 weeks (20 sessions total).	Outcome measured by a change in HAMD-17 score from baseline to 1-week post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of ≤7 is categorized as remission.

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory-II (BDI-II)	Daily for 4 weeks, 5 days per week, in addition to three follow-up visits at 1, 4, and 12 weeks post-treatment	Outcome measured by a change in BDI-II score from baseline to 1-week post-treatment. A 50% improvement in the score is considered a response to rTMS. A final score of ≤12 is categorized as remission.

Trial Locations

Locations (2)

UHN MRI-Guided rTMS Clinic, Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada