Physical Activity Program for TRD
Recruiting now · Not applicable
Conditions studied: Treatment-resistant Depression, Major Depressive Disorder
In brief
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).
Key facts
- Study ID
- NCT06404320
- Run by
- Unity Health Toronto
- People needed
- 30
- Starts
- 2024-09-19
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2025-04-30
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 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 depressive episode (MDE) as confirmed by the Mini International Neuropsychiatric Interview (MINI).
- 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).
You may not qualify 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 comorbidities (e.g., anxiety disorders, trauma-related disorders, etc.) will not be excluded.
- 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 completely about the study, and obtain consent are necessary.
Where it is running
- St. Michael's Hospital, Unity Health Toronto — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.