Status:
RECRUITING
Neural Mechanisms of Intermittent Theta Burst Stimulation in the Core Depression Network
Lead Sponsor:
The Royal Ottawa Mental Health Centre
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Repetitive Transcranial magnetic stimulation (TMS) uses magnetic fields to modulate brain activity. A novel form of repetitive TMS (rTMS), intermittent theta burst stimulation (iTBS), has emerged as a...
Detailed Description
Repetitive transcranial magnetic stimulation (rTMS) is a Health Canada approved treatment for major depression. Typical clinical rTMS treatment is delivered on the left dorsolateral prefrontal cortex ...
Eligibility Criteria
Inclusion
- Men or women aged 18 to 55 years of age
- Mini-International Neuropsychiatric Interview-confirmed diagnosis of MDD, as a single or recurring episode
- Symptoms of MDD have not improved after ≥ 1 but ≤ 7 adequate dose(s) of antidepressant trial(s) in the current depressive episode
- A baseline score of ≥ 15 on the 17-item Hamilton Rating Scale for Depression (HRSD-17)
- Have received a stable antidepressant regimen for at least four weeks prior to entering trial
- Are voluntary and competent to consent to study
- Can speak and read English
Exclusion
- Current or past (\< 3 months) substance (including nicotine) or alcohol abuse/dependence, as defined in DSM-5 criteria
- Positive urine test for illegal substances, cannabis, or cotinine
- Suicide attempt in the past three months and/or active suicidal intent
- Pregnancy (confirmed by urine test) and/or lactation
- Psychotic features in the current episode
- Any comorbid mental health disorders (including, but not limited to lifetime history of psychotic disorders, OCD, PTSD and/or bipolar I or II disorder) with the exception of anxiety/panic disorders and ADHD
- Significant unstable medical or neurologic illness confirmed by medical history and blood test at baseline (e.g. uncontrolled diabetes, or renal dysfunction)
- Organic cause to the depressive symptoms (e.g. thyroid dysfunctions), as ruled out by the referring physician
- Contraindication for TMS (e.g., personal history of epilepsy or convulsion, metallic head implant, pacemaker)
- Contraindication for MRI (e.g. metallic implant, claustrophobia)
- Have undergone a prior PET or SPECT research study
- ECT or rTMS treatment in the current depressive episode
- Benzodiazepine use
- Have a body mass index (BMI) higher then 35 or lower then 18
- Any other condition that, in the opinion of the investigators, would adversely affect the participant's ability to complete the study
Key Trial Info
Start Date :
April 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT05224206
Start Date
April 26 2023
End Date
January 1 2026
Last Update
September 9 2025
Active Locations (1)
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1
The Royal Ottawa Mental Health Centre
Ottawa, Ontario, Canada, K1Z 7K4