Completed

TREADTreatment With Exercise Augmentation for Depression (TREAD)

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

SSRI + LD

+ SSRI + PHD

Behavioral
Who is being recruted

Behavior

+ Behavioral Symptoms

+ Depression

From 18 to 70 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: April 2003
See protocol details

Summary

Principal SponsorUniversity of Texas Southwestern Medical Center
Last updated: September 23, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2003

Actual date on which the first participant was enrolled.

Partial response to antidepressant treatment is common in people with MDD and is associated with significant morbidity and reduced quality of life. Pharmacological therapies have been used to augment the effect of antidepressants; however, such therapies are associated with a range of adverse effects. Studies indicate that exercise may be safe and effective in augmenting depression treatment. This study will determine whether exercise can complement selective serotonin reuptake inhibitor (SSRI) therapy in people with MDD who have residual symptoms of depression despite drug treatment. Participants will be randomly assigned to either high frequency exercise or low frequency exercise for 12 weeks. Depression symptoms will be measured weekly. Quality of life and satisfaction with the study will also be measured. Depression scales and self-reports will be used to assess participants.

NCT00076258
Principal SponsorUniversity of Texas Southwestern Medical Center
Last updated: September 23, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

126 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorBehavioral SymptomsDepression

Criteria

7 inclusion criteria required to participate
8 to 12 weeks of SSRI treatment, with at least 6 weeks at adequate doses
Body mass index (BMI) less than 40 kg/m2
Diagnosis of Major Depressive Disorder
Physically capable of exercise
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12 exclusion criteria prevent from participating
Abnormal exercise stress test
Alcohol and/or substance abuse in the past 6 months
Comorbid disorders, including depression due to another comorbid condition, psychotic disorder, bipolar disorder, schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder (OCD)
Failure to respond to two or more adequate pharmacological treatments during the current depressive episode
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
A low dose aerobic exercise (LD) augmentation intervention to SSRI

Group II

Experimental
A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Texas Southwestern Medical Center at Dallas

Dallas, United StatesOpen University of Texas Southwestern Medical Center at Dallas in Google Maps
CompletedOne Study Center