BridgeMD
Compares treatment options for Depression
Official title Comparing the Efficacy of fMRI-Guided vs. Standard iTBS in Treating Depression
ClinicalTrials.gov ID: NCT06152705
What this study is testing
- What it's testing
- In this triple-blind randomized controlled trial, we ask if targeting intermittent theta burst stimulation (iTBS) based on individual resting state connectivity improves treatment outcomes in major depressive disorder (MDD). For the trial, we will recruit 210 patients with major depressive disorder.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- For inclusion in the study, participants must fulfill all the following criteria:
- voluntary and competent to consent to study,
- Adults aged 18 years old or older,
- can speak and read English,
- primary and/or predominant diagnosis of major depressive episode without psychotic features in the current episode (confirmed by a Mini-International...
You likely can't join if
- Participants fulfilling any of the following criteria will be excluded from the study:
- diagnosis of bipolar I or II disorder, based on the DSM-5 criteria
- 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...
- current use of illegal substances or cannabis (unless medical use, see note below), confirmed by urine drug screen
- 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), as ruled out by the referring physician
See the full eligibility criteria
- For inclusion in the study, participants must fulfill all the following criteria:
- voluntary and competent to consent to study,
- Adults aged 18 years old or older,
- can speak and read English,
- primary and/or predominant diagnosis of major depressive episode without psychotic features in the current episode (confirmed by a Mini-International Neuropsychiatric Interview),
- depressive symptoms have not improved after ≥ 1 adequate dose of antidepressant trial in the current depressive episode,
- 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),
- have been referred to rTMS treatment by their treating physician, and took a free and informed decision to follow this treatment,
- are able to adhere to treatment schedule,
- have stable psychotropic medications (including prescribed cannabis) or psychotherapy regimen for at least four weeks prior to entering the trial,
- have an education-adjusted score of ≥ 24 at the Mini-Mental State Evaluation (MMSE) if they are aged ≥ 65.
- Participants fulfilling any of the following criteria will be excluded from the study:
- diagnosis of bipolar I or II disorder, based on the DSM-5 criteria
- 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...
- current use of illegal substances or cannabis (unless medical use, see note below), confirmed by urine drug screen
- 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), as ruled out by the referring physician
- acute suicidality or threat to life from self-neglect,
- are pregnant or breastfeeding, or thinking of becoming pregnant during course of treatment (pregnancy will be assessed by a urine test),
- have a specific contraindication for TMS (e.g., personal history of epilepsy or seizure, metallic head implant, pacemaker),
- unwilling to maintain current antidepressant regimen,
- are taking more than 1 mg of lorazepam per day or equivalent,
- any other condition that, in the opinion of the investigators, would adversely affect the participant's ability to complete the study,
- any contraindications for MRI
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ottawa, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.