Predictors of Depression Treatment Response to Exercise

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02583867

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Major Depressive Disorder	Behavioral: Exercise	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Predictors of Depression Treatment Response to Exercise

Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Feb 1, 2019

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Depressive Symptoms [12 weeks]
Depressive symptoms will be assessed using the clinician-rated Inventory for Depressive Symptomatology (IDS-C)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Southwestern Medical Center	Dallas	Texas	United States	75390-9119

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

Principal Investigator: Chad Rethorst, PhD, UT Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT02583867

Other Study ID Numbers:

STU 052015-018

First Posted:

Oct 22, 2015

Last Update Posted:

Apr 1, 2019

Last Verified:

Mar 1, 2019

Additional relevant MeSH terms:

Depression

Depressive Disorder

Depressive Disorder, Major

Study Results

No Results Posted as of Apr 1, 2019