Brief Summary

High frequency repetitive transcranial magnetic stimulation (rTMS) has been shown to be safe, feasible, and acceptable. Conventionally, rTMS investigations have relied on rational decision trees for dosage determination. The purpose of this study is to systematically examine an accelerated protocol of intermittent theta burst (iTBS). Study 1 aims to provide a quantifiable dose-response curve for iTBS and depressive symptom reduction in major depression. Study 2 aims to determine the role of individual variations of their functional networks compared to the site of stimulation and clinical outcomes.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable depression

Timeline

7mo left

Started May 2021

Longer than P75 for not_applicable depression

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5.5 years study duration

Study Progress90%

May 2021Dec 2026

First Submitted

Initial submission to the registry

December 1, 2020

Completed

7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed

6 months until next milestone

Study Start

First participant enrolled

May 25, 2021

Completed

5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

5.5 years

First QC Date

December 1, 2020

Last Update Submit

March 27, 2026

Conditions

Depression Anxiety

Outcome Measures

Primary Outcomes (3)

Depression severity (change in score)
Depression severity as assessed by: 1\. Hamilton Scale for Depression (HAM-D) Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. 10 - 13 mild; 14-17 mild to moderate; \>17 moderate to severe.
Day 1, post-treatment point of 1 month
Depression severity (change in score)
Depression severity as assessed by: 2\. Montgomery-Asberg Depression Rating Scale (MADRS) Rating lies on the defined scale steps (0, 2, 4, 6) or between them (1, 3, 5). Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Day 1, post-treatment point of 1 month
Depression severity (change in score)
Depression severity as assessed by: 3\. Beck Depression Inventory-II (BDI-II) Rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.
Day 1, post-treatment point of 1 month

Secondary Outcomes (12)

Comorbid symptom severity, functional impairment, acceptability, and tolerability
Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Day 1, post-treatment point of 1 month
Comorbid symptom severity, functional impairment, acceptability, and tolerability
Day 1, post-treatment point of 1 month
+7 more secondary outcomes

Study Arms (11)

Dose 1

EXPERIMENTAL

All participants will be randomized to one of 10 doses of accelerated rTMS. All doses are active and within established therapeutic levels of rTMS. Dose 1 is five sessions of 600 pulses at 120% of resting motor threshold. Intermittent theta burst triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 seconds.