Comparing the Efficacy of FMRI-Guided Vs. Standard ITBS in Treating Depression

Launched by THE ROYAL OTTAWA MENTAL HEALTH CENTRE · Nov 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat major depressive disorder (MDD) using a technique called intermittent theta burst stimulation (iTBS). The goal is to see if targeting the treatment based on individual brain activity—measured through an MRI scan—leads to better results compared to the standard approach. The trial will involve 210 adults with MDD who have not responded well to previous antidepressant medications. To be eligible, participants should be at least 18 years old, speak and read English, and have moderate depressive symptoms. They also need to be stable on their current medications and have been referred for this type of treatment by their doctor.

Participants in the trial can expect to undergo a 30-40 minute MRI scan before starting 6 weeks of treatment. They will be randomly assigned to receive iTBS either using a standard method or a personalized method based on their MRI results. The main goal is to see if their depression improves significantly, while additional measures will look at changes in anxiety, quality of life, and other related symptoms. It’s important to note that those with certain medical conditions, a history of substance abuse, or who are pregnant may not qualify for the study. This trial is currently recruiting participants who meet the criteria and are seeking new options for managing their depression.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• For inclusion in the study, participants must fulfill all the following criteria:
• • 1. voluntary and competent to consent to study,
• • 2. Adults aged 18 years old or older,
• • 3. can speak and read English,
• • 4. primary and/or predominant diagnosis of major depressive episode without psychotic features in the current episode (confirmed by a Mini-International Neuropsychiatric Interview),
• • 5. depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant trial in the current depressive episode,
• • 6. moderate symptoms in the current depressive episode as indexed by a score of at least 15 on the Grid 17-item Hamilton Rating Scale for Depression (Grid HRSD-17),
• • 7. have been referred to rTMS treatment by their treating physician, and took a free and informed decision to follow this treatment,
• • 8. are able to adhere to treatment schedule,
• • 9. have stable psychotropic medications (including prescribed cannabis) or psychotherapy regimen for at least four weeks prior to entering the trial,
• • 10. have an education-adjusted score of ≥ 24 at the Mini-Mental State Evaluation (MMSE) if they are aged ≥ 65.
• Exclusion criteria:
• Participants fulfilling any of the following criteria will be excluded from the study:
• • 1. diagnosis of bipolar I or II disorder, based on the DSM-5 criteria
• • 2. current or past (\< 3 months) substance (excluding caffeine or nicotine) or alcohol use disorder, as defined in DSM-5 criteria. Based on the DSM-5 criteria, mild cannabis or alcohol use disorder would be permissible in the past 3 months, moderate to severe would be an exclusion.
• • 3. current use of illegal substances or cannabis (unless medical use, see note below), confirmed by urine drug screen
• • 4. have a concomitant major unstable medical or neurologic illness (e.g. uncontrolled diabetes or renal dysfunction),
• • 5. organic cause to the depressive symptoms (e.g. thyroid dysfunctions), as ruled out by the referring physician
• • 6. acute suicidality or threat to life from self-neglect,
• • 7. are pregnant or breastfeeding, or thinking of becoming pregnant during course of treatment (pregnancy will be assessed by a urine test),
• • 8. have a specific contraindication for TMS (e.g., personal history of epilepsy or seizure, metallic head implant, pacemaker),
• • 9. unwilling to maintain current antidepressant regimen,
• • 10. are taking more than 1 mg of lorazepam per day or equivalent,
• • 11. any other condition that, in the opinion of the investigators, would adversely affect the participant's ability to complete the study,
• • 12. any contraindications for MRI
• • 13. have failed a course of ECT within the current depressive episode due to the lower likelihood of response to rTMS (if they have had failed ECT in the past, this does not exclude them)