Comparing Uni- and Bi-lateral TBS in Major Depression
ConditionMajor Depressive Episode
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Royal Ottawa Mental Health Centre
About this trial
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.
Eligibility criteria
Qualifiers
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 and/or predominant diagnosis of major depressive episode without psychotic features in the current depressive episode (confirmed by a Mini-International Neuropsychiatric Interview),
Disqualifiers
current or past (< 3 months) substance (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in the Diagnostic and Statistical Manual 5th Edition (DSM-5) criteria. Based on the DSM-5 criteria, mild cannabis or alcohol use would be permissible in the past 3 months, moderate to severe would be an exclusion
current use of illegal substances or recreational cannabis
have a concomitant major unstable medical or neurologic illness (e.g. uncontrolled diabetes or renal dysfunction),
organic cause to the depressive symptoms (e.g. thyroid dysfunctions), determined by the referring physician
Trial design
Treatments tested in this trial
- Theta burst stimulation
Treatment groups
256 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov