Actively Recruiting
Comparing Uni- and Bi-lateral TBS in Major Depression
Led by The Royal Ottawa Mental Health Centre · Updated on 2023-12-04
256
Participants Needed
1
Research Sites
350 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Theta burst stimulation (TBS) is a very promising new treatment for major depression that allows a 15-fold reduction in duration of daily sessions. However, no large scale naturalistic study has assessed the superiority of bilateral TBS in comparison with unilateral left TBS. In fact, no TBS study thus far has included both unipolar and bipolar depression, or other psychiatric comorbidities such as anxiety. Maintenance has yet to be studied with TBS, along with an effective maintenance protocol to prevent relapse. Our study aims to explore and address these gaps.
CONDITIONS
Official Title
Comparing Uni- and Bi-lateral TBS in Major Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary and competent to consent to study
- Female or male aged 18 years old or older
- Can speak and read English and/or French
- Primary or predominant diagnosis of major depressive episode without psychotic features confirmed by Mini-International Neuropsychiatric Interview
- Depressive symptoms not improved after at least one adequate dose of antidepressant trial in current episode
- Moderate symptoms with a score of at least 15 on the 17-item Hamilton Rating Scale for Depression
- Referred to rTMS treatment by treating physician and freely chosen to follow treatment
- Able to adhere to treatment schedule
- Stable psychiatric medication or psychotherapy regimen for at least four weeks before trial
- Education-adjusted Mini-Mental State Evaluation score of 24 or higher if aged 65 or older
You will not qualify if you...
- Current or past (less than 3 months) substance or alcohol abuse/dependence except mild cannabis or alcohol use
- Current use of illegal substances or recreational cannabis
- Major unstable medical or neurological illness such as uncontrolled diabetes or renal dysfunction
- Organic cause of depressive symptoms such as thyroid dysfunction
- Acute suicidality or threat to life from self-neglect
- Pregnant, breastfeeding, or planning pregnancy during treatment
- Contraindications for TMS like epilepsy, seizure history, metallic head implant, or pacemaker
- Unwilling to maintain current antidepressant regimen
- Taking more than 1 mg of lorazepam or equivalent
- Any condition that would affect ability to complete the study as judged by investigators
- Failure of electroconvulsive therapy during current depressive episode
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Royal Ottawa Mental Health Centre
Ottawa, Ontario, Canada, K1Z 7K4
Actively Recruiting
Research Team
S
Stacey Shim, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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