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Completed

NCT Number: NCT02583867

Predictors of Depression Treatment Response to Exercise

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75390-9119, United States

About this study

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. Blood samples will be collected at baseline for analysis of inflammatory cytokines, as well as other potential biological predictors of treatment outcomes (i.e., BDNF). Assessments will gather data on potential clinical predictors of treatment outcomes (anxiety, stress, sleep). Assessments and sample collection will also occur at 3 time points during the treatment period (Weeks 4, 8, and 12) to identify mediators and correlates of treatment effects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Exercise

Behavioral

Subjects will engage in supervised exercise sessions for 12 weeks. Each week will consist of at least three exercise sessions with a total duration of weekly exercise of approximately 150 minutes.

Primary outcomes

  1. Depressive Symptoms

    Time frame: 12 weeks

    Depressive symptoms will be assessed using the clinician-rated Inventory for Depressive Symptomatology (IDS-C)

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2015
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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