NCT06404320Recruiting
Physical Activity Program for TRD
Remotely Delivered Physical Activity Program for Treatment-Resistant Depression: A Pilot Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 30 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 29 Apr 2024
- Start date
- 19 Sept 2024
- Primary completion date
- Dec 2025
- Lead sponsor
- Unity Health Toronto
- Diseases
- Depression
- NCT number
- NCT06404320
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 19 Sept 2024 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- 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.
- Taking medication that interferes with heart rate response to exercise, such as beta blockers.
Other
- Current symptoms of mania, hypomania, mixed episodes, or psychosis.
- 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 exercise-induced asthma.
- Do not own a smartphone.
- Do not have reliable access to the Internet.
Who the study is looking for
- 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).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Michael's Hospital, Unity Health Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.