Bilateral TBS for Major Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Royal Ottawa Mental Health Centre, Ottawa, CanadaMajor DepressionTheta burst stimulation - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the effectiveness of a new, shorter treatment for major depression, comparing it to a standard treatment.

Eligible Conditions
  • Major Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 4 Secondary · Reporting Duration: 7 months

6 months
Cortical Activity - Maintenance Phase
Remission - Maintenance Phase (Hamilton Rating Scale for Depression-17 Score)
Remission - Maintenance Phase Quick Inventory of Depression Symptomology-Self Report)
Response - Maintenance Phase (Hamilton Rating Scale for Depression-17 score)
Mental Depression
7 months
Resting State Connectivity
Week 4
Remission - Treatment Phase (Hamilton Rating Scale for Depression-17 Score)
Remission - Treatment Phase (Quick Inventory of Depression Symptomology-Self Report)
Week 6
Cortical Activity - Treatment Phase
Response - Treatment Phase (Hamilton Rating Scale for Depression-17 score)
Response - Treatment Phase (Quick Inventory of Depression Symptomology-Self Report)

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Bilateral TBS
1 of 4
Maintenance Phase: Fixed
1 of 4
Unilateral TBS
1 of 4
Maintenance Phase: Flexible
1 of 4

Active Control

256 Total Participants · 4 Treatment Groups

Primary Treatment: Bilateral TBS · No Placebo Group · N/A

Bilateral TBS
Device
ActiveComparator Group · 1 Intervention: Theta burst stimulation · Intervention Types: Device
Maintenance Phase: Fixed
Device
ActiveComparator Group · 1 Intervention: Theta burst stimulation · Intervention Types: Device
Unilateral TBS
Device
ActiveComparator Group · 1 Intervention: Theta burst stimulation · Intervention Types: Device
Maintenance Phase: Flexible
Device
ActiveComparator Group · 1 Intervention: Theta burst stimulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 7 months

Who is running the clinical trial?

The Royal Ottawa Mental Health CentreLead Sponsor
12 Previous Clinical Trials
858 Total Patients Enrolled
Sara Tremblay, PhDPrincipal InvestigatorThe Royal Ottawa Mental Health Centre
1 Previous Clinical Trials
22 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 18 years old or older, regardless of your gender.
You must be able to speak and read English and/or French.

Frequently Asked Questions

What is the current participant count for this medical experiment?

"Affirmative. Clinicaltrials.gov documents that this medical trial, first published on December 12th 2019, is currently recruiting participants from one location. A total of 256 patients need to be enrolled in the research study." - Anonymous Online Contributor

Unverified Answer

Is this research initiative still welcoming participants?

"According to the information hosted by clinicaltrials.gov, this trial is actively recruiting and was initially posted on December 12th 2019 with a most recent edit occurring on June 7th 2022." - Anonymous Online Contributor

Unverified Answer

What purpose does this research endeavor seek to achieve?

"The primary metric of this 6-month trial is Remission - Treatment Phase (Hamilton Rating Scale for Depression-17 Score). Secondary outcomes include Response - Maintenance Phase and Response - Treatment Phase, both assessed by the Quick Inventory of Depression Symptomology-Self Report. Lastly, there's also a measure for Remission as defined by a score ≤ 6 on the same scale." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.