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New treatment option for Major Depressive Disorder (MDD)
Official title Feasibility Trial of Exercise as a Priming Strategy for rTMS Treatment in Difficult-to-Treat Depression
ClinicalTrials.gov ID: NCT06773949
What this study is testing
- What it's testing
- The goal of this study is to collect feasibility data on combining structured exercise aimed to improve physical fitness, and intermittent TBS (iTBS) in treating individuals diagnosed with difficult-to-treat depression who are physically inactive. By conducting this trial, we will compare the therapeutic benefits of the combined approach against the standard treatment of iTBS alone (without exercise).
- 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 to 75
You may be able to join if
- Are between 18-75 years old.
- Able to provide voluntary informed consent.
- Diagnosis of MDD or Persistent Depressive Disorder, without psychotic features, confirmed by MINI for DSM-5.
- Depressive symptoms have not improved after ≥ 1 adequate antidepressant trial in the current episode (i.e., difficult-to-treat MDD), based on the...
- Baseline score of ≥15 on the HRSD-17.
You likely can't join if
- Diagnosis of bipolar I or II disorder, based on DSM-5 criteria.
- Current or past (\<3 months) substance (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in DSM-5 criteria.
- Current use of illegal substances.
- Current use of cannabis.
- Concomitant major unstable medical or neurologic illness (e.g., uncontrolled diabetes or renal dysfunction).
- Organic cause of the depressive symptoms (e.g. thyroid dysfunctions), determined by the referring physician.
See the full eligibility criteria
- Are between 18-75 years old.
- Able to provide voluntary informed consent.
- Diagnosis of MDD or Persistent Depressive Disorder, without psychotic features, confirmed by MINI for DSM-5.
- Depressive symptoms have not improved after ≥ 1 adequate antidepressant trial in the current episode (i.e., difficult-to-treat MDD), based on the Antidepressant Treatment History Form (ATHF).
- Baseline score of ≥15 on the HRSD-17.
- No change in psychotropic medications or psychotherapy regimen at least 4 weeks prior to entering the trial
- Physically inactive as per the International Physical Activity Questionnaire - Short Form (IPAQ-SF).
- Able to engage in structured exercise as per the Get Active Questionnaire (GAQ).
- Able to adhere to the proposed treatment schedule.
- Diagnosis of bipolar I or II disorder, based on DSM-5 criteria.
- Current or past (\<3 months) substance (excluding caffeine or nicotine) or alcohol abuse/dependence, as defined in DSM-5 criteria.
- Current use of illegal substances.
- Current use of cannabis.
- Concomitant major unstable medical or neurologic illness (e.g., uncontrolled diabetes or renal dysfunction).
- Organic cause of the depressive symptoms (e.g. thyroid dysfunctions), determined by the referring physician.
- Acute suicidality or threat to life from self-neglect.
- Pregnant or breastfeeding, or thinking of becoming pregnant during course of treatment.
- Contraindication for TMS and MRI (e.g., personal history of epilepsy or seizure, metallic head implant, pacemaker), confirmed by TMS Adult Safety Scale (TASS) and MRI pre-screener.
- Unwilling to maintain current psychotropic medication and/or psychotherapy regimen for the four weeks prior to and for the duration of the study.
- Taking more than 1 mg/day of lorazepam or equivalent.
- Any other condition that, in the opinion of the investigators which would adversely affect the participant's ability to complete the study.
- Physically active: performing exercise and/or physical activity levels meeting the cut-off for "minimally active" on the IPAQ-SF.
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 to 75 years. 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.