Predictors of Depression Treatment Response to Exercise

NCT02583867 | Completed Phase 3

• 1 other identifier: STU 052015-018
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Depressive Symptoms

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

  12 weeks

Study Arms (1)

Exercise

EXPERIMENTAL

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

Interventions

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.

Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390-9119, United States

Location

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Chad Rethorst, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: October 22, 2015
• Study Start: December 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: April 1, 2019

Record last verified: 2019-03

Locations

US (1)