Predictors of Depression Treatment Response to Exercise

Completed · Phase 3

Conditions studied: Depression, Major Depressive Disorder

In brief

50 subjects with Major Depressive Disorder who are not currently receiving treatment will be enrolled in a 12-week exercise program, supervised by a trained exercise interventionist.

Key facts

Study ID

NCT02583867

Run by

University of Texas Southwestern Medical Center

People needed

38

Starts

2015-12-01

Expected to finish

2019-02-01

Last updated by the study team

2019-04-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with MDD
• Ages 18-65 will be included.
• Ability to understand and willingness to provide written informed consent.
• Willing to provide contact information.
• Medical clearance with protocol-defined stress testing (in accordance with American College of Sports Medicine (ACSM) guidelines) from protocol approved medical personnel. Details of guidelines and related testing protocol are provided in the study Manual of Procedures.
• Able to comprehend and communicate in English.

You may not qualify if…

• Have a medical condition contraindicating exercise participation
• Are currently physically active - defined as moderate intensity physical activity on 3 or more days per week for the last month
• Currently receiving antidepressant medication treatment
• Currently considered a high suicide risk and/or high risk for being unable to complete the study due to the need for psychiatric hospitalization, suicide attempts or suicidality, significant self-mutilation, or other self-injurious or destructive behavior based on the judgment of the site PI, medical personnel, or designee.
• Pregnancy.
• Current psychotic disorder. Other comorbid psychiatric diagnosis that, in the investigator's judgment, will pose a safety issue or make it difficult for the participant to understand or complete the intervention.
• Anticipated circumstances over the 6-month course of the trial that would render the participant unlikely to complete the study in the judgment of the PI or designee.
• Any reason not listed herein yet, determined by the PI, medical personnel, or designee that constitutes good clinical practice and that would in the opinion of the PI, medical personnel, or designee make participation in the study hazardous.
• Are currently enrolled in another research study, and participation in that study contraindicates participation in the current study

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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