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Predictors of Depression Treatment Response to Exercise

Primary Purpose

Depression, Major Depressive Disorder

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Exercise

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise

Arm Description

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.

Outcomes

Primary Outcome Measures

Depressive Symptoms

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02583867

First Posted

October 13, 2015

Last Updated

March 29, 2019

Sponsor

University of Texas Southwestern Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02583867

Brief Title

Predictors of Depression Treatment Response to Exercise

Official Title

Predictors of Depression Treatment Response to Exercise

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

December 2015 (undefined)

Primary Completion Date

February 2019 (Actual)

Study Completion Date

February 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Description

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 Outcome Measure Information:

Title

Depressive Symptoms

Description

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chad Rethorst, PhD

Organizational Affiliation

UT Southwestern Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9119

Country

United States

12. IPD Sharing Statement

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Predictors of Depression Treatment Response to Exercise

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