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Behavioural Intervention

Theta Burst Stimulation for Depression

N/A
Recruiting
Led By Sara Tremblay, PhD
Research Sponsored by The Royal Ottawa Mental Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men or women aged 18 to 55 years of age
Symptoms of MDD have not improved after ≥ 1 but ≤ 7 adequate dose(s) of antidepressant trial(s) in the current depressive episode
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 40 minutes after itbs
Awards & highlights

Study Summary

This trial will help improve understanding of how a new treatment for depression, called intermittent theta burst stimulation (iTBS), works. 22 people with major depressive episodes will receive either iTBS or a sham treatment, and positron emission tomography (PET) and magnetic resonance imaging (MRI) will be used to compare the effects of the two treatments on brain activity.

Who is the study for?
This trial is for adults aged 18-55 with major depressive disorder (MDD) who haven't improved after 2-7 antidepressant treatments. They must have a certain depression score, be on stable medication for four weeks, and not have a history of substance abuse or significant medical conditions. Pregnant women and those with metal implants or severe psychiatric disorders are excluded.Check my eligibility
What is being tested?
The study tests intermittent theta burst stimulation (iTBS), a type of brain stimulation therapy for depression that's quicker than standard treatments. Participants will undergo iTBS compared to sham treatment using PET and MRI scans in a double-blind experiment, followed by six weeks of daily iTBS sessions.See study design
What are the potential side effects?
While the document doesn't list specific side effects, TMS can generally cause headaches, scalp discomfort at the site of stimulation, tingling or spasms in facial muscles, lightheadedness, and rare risk of seizures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 55 years old.
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My depression hasn't improved after 1 to 7 treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~40 minutes after itbs
This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 minutes after itbs for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neural mechanisms of iTBS measured by [18F]FDG uptake in the sgACC
Neuroimaging predictors of iTBS response to treatment - primary measures
Secondary outcome measures
Neuroimaging predictors of iTBS response to treatment - Beck Anxiety Inventory (BAI)
Neuroimaging predictors of iTBS response to treatment - QIDS-SR16
Neuroimaging predictors of iTBS response to treatment - Quality of life (Q-LES-Q-SF)
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active iTBSActive Control1 Intervention
Intermittent Theta Burst Stimulation (iTBS) will be applied to the left DLPFC. Participants will receive daily sessions (on weekdays) for 6 weeks.
Group II: Sham iTBS/Active iTBSPlacebo Group1 Intervention
Intermittent Theta Burst Stimulation (iTBS) or realistic sham iTBS will be applied to the left DLPFC. Both sessions will be one week apart.

Find a Location

Who is running the clinical trial?

The Royal Ottawa Mental Health CentreLead Sponsor
18 Previous Clinical Trials
2,068 Total Patients Enrolled
5 Trials studying Depression
613 Patients Enrolled for Depression
Sara Tremblay, PhDPrincipal InvestigatorThe Royal Ottawa Mental Health Centre
2 Previous Clinical Trials
466 Total Patients Enrolled
2 Trials studying Depression
466 Patients Enrolled for Depression

Media Library

Theta burst stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05224206 — N/A
Depression Research Study Groups: Active iTBS, Sham iTBS/Active iTBS
Depression Clinical Trial 2023: Theta burst stimulation Highlights & Side Effects. Trial Name: NCT05224206 — N/A
Theta burst stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05224206 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is my participation permissible in this trial?

"To qualify for this clinical trial, participants must have a diagnosis of psychosis and be between 18-55 years old. Currently, 22 potential patients are being sought out."

Answered by AI

What is the current size of the cohort involved in this clinical research?

"Affirmative. According to clinicaltrials.gov, this research effort is currently recruiting participants and was first posted on June 1st 2022 with its latest edit occurring on May 13th 2022. The study requires 22 patients from a single site for enrollment."

Answered by AI

Are new participants being accepted for this medical investigation?

"Affirmative. Clinicaltrials.gov shows that this clinical trial is actively recruiting participants, having been initially posted on June 1st 2022 and recently updated on May 13th of the same year. 22 volunteers are desired to be enrolled at a single site."

Answered by AI

Is participation in this study restricted to persons aged fifty or older?

"Individuals wishing to join this clinical study must fit the age criterion of 18-55 years old. Meanwhile, there are 107 separate studies devoted to minors and 596 for seniors over 65."

Answered by AI

What objectives are researchers hoping to achieve through this experiment?

"The primary outcome of this trial, measured over a 40-minute post iTBS timeframe, will be the Neuroimaging predictors of response to treatment. As secondary measures, self-rated Beck Anxiety Inventory (BAI), Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWBS) and Quality of Life Enjoyment and Satisfaction Questionnaire -Short Form (Q-LES-QF-SF) scores are utilized in order to assess anxiety levels, overall mental wellbeing and quality of life enjoyment/satisfaction respectively. For all outcomes improvement is defined as a 50% reduction in pre-treatment symptom severity."

Answered by AI

Who else is applying?

What site did they apply to?
The Royal Ottawa Mental Health Centre
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I've tried 4 different antidepressants without success, it's been treatment resistant for 17 years. I've been living a healthy lifestyle but nothing improves this. I don't have a family doctor but the diagnosis is clear on medical record. I have prescription still but currently unmedicated and have been for the past 2 years.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Neural Mechanisms of Intermittent Theta Burst Stimulation in the Core Depression Network
Sara Tremblay 2023. "Neural Mechanisms of Intermittent Theta Burst Stimulation in the Core Depression Network". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05224206.
~11 spots leftby Jun 2025
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