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New treatment option for Major Depressive Disorder
Official title RESISTance Exercise for Depression Trial
ClinicalTrials.gov ID: NCT06110897
What this study is testing
- What it's testing
- 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 training program for the treatment of Major Depressive Disorder (MDD) in 200 adults.
- 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
- 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...
- 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...
- Safe to exercise based on physical activity screening questions or physician clearance
You likely can't join if
- 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...
- Exhibit behavioral disturbance (e.g., aggression, mild-moderate cognitive impairment) that would significantly interfere with study participation, as...
See the full eligibility criteria
- 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...
- Safe to exercise based on physical activity screening questions or physician clearance
- Willing to be assigned by chance to either condition
- have a Smartphone
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ames, Iowa, United States
- Madison, Wisconsin, United States
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 Ames, Iowa, United States; Madison, Wisconsin, United States. 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.