NCT05224206Active, not recruiting
Neural Mechanisms of Intermittent Theta Burst Stimulation in the Core Depression Network
Source: ClinicalTrials.gov · Last updated 15 May 2026
Brief summary (registry, in English)
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 promising new treatment for depression. This technique may be advantageous due to its very short duration and potentially stronger effect on brain activity in comparison with standard rTMS. However, the exact effect of iTBS on the activity of the brain in clinical populations remains poorly understood. This project aims to improve understanding of the mechanisms of action of iTBS by comparing its neuronal effect to sham treatment in 22 individuals with a diagnosis of major depressive episode, using positron emission tomography (PET) and magnetic resonance imaging (MRI) in a double-blind cross-over experiment, followed by a 6-week daily treatment course of iTBS.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- First submitted
- 13 Oct 2021
- Start date
- 26 Apr 2023
- Primary completion date
- 3 Jan 2027
- Lead sponsor
- The Royal Ottawa Mental Health Centre
- Diseases
- Depression
- NCT number
- NCT05224206
What you commit to
- Study type: Interventional
- Planned participants: 22
- From 26 Apr 2023 to the primary completion date, 3 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication for MRI (e.g. metallic implant, claustrophobia)
- Have undergone a prior PET or SPECT research study
Other illness
- 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)
- Contraindication for TMS (e.g., personal history of epilepsy or convulsion, metallic head implant, pacemaker)
- Any other condition that, in the opinion of the investigators, would adversely affect the participant's ability to complete the study
Other
- 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
- Organic cause to the depressive symptoms (e.g. thyroid dysfunctions), as ruled out by the referring physician
- ECT or rTMS treatment in the current depressive episode
- Benzodiazepine use
- Have a body mass index (BMI) higher then 35 or lower then 18
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Royal Ottawa Mental Health Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.