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.

Study Overview

• Status: Completed
• Conditions: Depression; Major Depressive Disorder
• Intervention / Treatment: Behavioral: Exercise

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390-9119
      • UT Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnosed with MDD
2. Ages 18-65 will be included.
3. Ability to understand and willingness to provide written informed consent.
4. Willing to provide contact information.
5. 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.
6. Able to comprehend and communicate in English.

Exclusion Criteria:

1. Have a medical condition contraindicating exercise participation
2. Are currently physically active - defined as moderate intensity physical activity on 3 or more days per week for the last month
3. Currently receiving antidepressant medication treatment
4. 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.
5. Pregnancy.
6. 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.
7. 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.
8. 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.
9. Are currently enrolled in another research study, and participation in that study contraindicates participation in the current study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; Participants will complete an exercise dose of 15 kilocalories per kilogram of bodyweight per week (KKW). This is equivalent to approximately 150 minutes/week of aerobic exercise. This dose will be completed in at least 3 sessions per week for 12 weeks.	Behavioral: Exercise; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive Symptoms	Depressive symptoms will be assessed using the clinician-rated Inventory for Depressive Symptomatology (IDS-C)	12 weeks

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Chad Rethorst, PhD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: October 13, 2015
• First Submitted That Met QC Criteria: October 20, 2015
• First Posted (Estimate): October 22, 2015

Study Record Updates

• Last Update Posted (Actual): April 1, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: STU 052015-018