Status:
RECRUITING
RESISTance Exercise for Depression Trial
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Iowa State University
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Depression is a leading cause of disability worldwide and current treatments are ineffective for many people. This trial will investigate the efficacy of a 16-week high vs low dose resistance exercise...
Detailed Description
Frontline treatments for major depressive disorder (MDD), including psycho- and pharmacotherapy, have limited effectiveness, and there is a critical need to develop and test novel, efficacious treatme...
Eligibility Criteria
Inclusion
- Be diagnosed with DSM-5 MDD, confirmed via Structured Clinical Interview for DSM-5 (SCID).
- Have current depressive symptoms of at least mild severity defined by the Hamilton Rating Scale of Depression 17 greater than or equal to 8 (HAMD; using the GRID-HAMD evaluated by trained, masked raters)
- Be ages 18-65
- EITHER not taking any mental health medications or seeking other mental health treatment (e.g., behavioral, psychological) OR be on a stable mental health medication and/or treatment regimen for the past 8 weeks, and intend to maintain that regimen for the duration of the study
- Safe to exercise based on physical activity screening questions or physician clearance
- Willing to be randomized to either condition
- have a Smartphone
Exclusion
- Currently pregnant, nursing, or planning to become pregnant during the trial
- Class III+ obesity
- Diagnosed with lifetime or current Psychosis, Mania, or Bipolar Disorder, via the SCID
- Diagnosed with current Substance Use Disorder, via the SCID
- Active suicidal ideation with specific plan and intent ('5' score on Suicidal Ideation from Columbia Suicide Severity Rating Scale), which would necessitate immediate emergent care
- Exhibit behavioral disturbance (e.g., aggression, mild-moderate cognitive impairment) that would significantly interfere with study participation, as assessed by clinical research personnel
- Currently meets resistance exercise recommendations (2 days per week) for the last 8 weeks
- Self-reporting a concussion/traumatic brain injury within the last 3 months
- Having cardiovascular disease, uncontrolled hypertension, or uncontrolled diabetes
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06110897
Start Date
January 1 2024
End Date
May 31 2028
Last Update
October 23 2025
Active Locations (2)
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1
Iowa State University
Ames, Iowa, United States, 50010
2
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53705