BridgeMD
New treatment option for Treatment-resistant Depression
Official title Physical Activity Program for TRD
ClinicalTrials.gov ID: NCT06404320
What this study is testing
- What it's testing
- This is a pilot study examining the delivery of a remotely delivered, one-on-one, individualized physical activity (PA) program in adult participants with treatment-resistant depression (TRD).
- 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 65
You may be able to join if
- Sedentary adults (engage in less than 60 minutes of moderate-to-vigorous PA per week) between the ages of 18 and 65 years, inclusive, capable of...
- Participants meeting diagnostic criteria for major depressive disorder without psychotic symptoms according to the Diagnostic and Statistical Manual...
- A Montgomery-Åsberg Depression Rating Scale total score of ≥ 7 at screening (mild-to-severe MDE).
- Failure of at least two trials of antidepressant therapy of adequate dose and duration during the current episode as established by the...
- Receiving treatments congruent with Canadian Network for Mood and Anxiety Treatments guidelines with no changes to treatments one month before...
You likely can't join if
- Current symptoms of mania, hypomania, mixed episodes, or psychosis.
- Have received a diagnosis of alcohol or a substance use disorder within the past 3 months or as confirmed by the MINI. Other secondary psychiatric...
- Pregnant females.
- Acute risk for a cardiovascular event (i.e., cardiovascular event in the past within the past 12 months).
- Have any medical contraindications to exercise according to the Physical Activity Readiness Questionnaire.
- Self-reported balance, gait, or locomotion difficulties that would preclude participation in a PA program.
See the full eligibility criteria
- Sedentary adults (engage in less than 60 minutes of moderate-to-vigorous PA per week) between the ages of 18 and 65 years, inclusive, capable of giving informed consent.
- Participants meeting diagnostic criteria for major depressive disorder without psychotic symptoms according to the Diagnostic and Statistical Manual of Mental Disorders - 5th Ed. and currently experiencing a major...
- A Montgomery-Åsberg Depression Rating Scale total score of ≥ 7 at screening (mild-to-severe MDE).
- Failure of at least two trials of antidepressant therapy of adequate dose and duration during the current episode as established by the Antidepressant Treatment History Form and self-report.
- Receiving treatments congruent with Canadian Network for Mood and Anxiety Treatments guidelines with no changes to treatments one month before screening (28 days).
- Current symptoms of mania, hypomania, mixed episodes, or psychosis.
- Have received a diagnosis of alcohol or a substance use disorder within the past 3 months or as confirmed by the MINI. Other secondary psychiatric comorbidities (e.g., anxiety disorders, trauma-related disorders, etc.)...
- Pregnant females.
- Acute risk for a cardiovascular event (i.e., cardiovascular event in the past within the past 12 months).
- Have any medical contraindications to exercise according to the Physical Activity Readiness Questionnaire.
- Self-reported balance, gait, or locomotion difficulties that would preclude participation in a PA program.
- Have any other condition that, in the opinion of the investigator(s), would adversely affect the subject's ability to complete the study or its measures.
- Have exercise-induced asthma.
- Taking medication that interferes with heart rate response to exercise, such as beta blockers.
- Do not own a smartphone.
- Do not have reliable access to the Internet.
- Have previously received intravenous ketamine treatment in the last 2 months. Non-English-speaking individuals are excluded because the ability to communicate study information, answer questions accurately and...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, 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.