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Completed

NCT Number: NCT00076258

Adding Exercise to Antidepressant Medication Treatment for Depression

This study will assess the effectiveness of an exercise program in improving antidepressant medication treatment for individuals with major depressive disorder (MDD).

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Major Depressive Disorder
  • Score of 14 or higher on the Hamilton Depression Scale (HAM-D)
  • 8 to 12 weeks of SSRI treatment, with at least 6 weeks at adequate doses
  • Sedentary lifestyle
  • Physically capable of exercise
  • Body mass index (BMI) less than 40 kg/m2
  • Willing and able to comply with study requirements

Exclusion criteria

  • Significant cardiovascular disease or other medical conditions
  • Uncontrolled hypertension
  • Abnormal exercise stress test
  • Hematologic disorders
  • Comorbid disorders, including depression due to another comorbid condition, psychotic disorder, bipolar disorder, schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder (OCD)
  • Alcohol and/or substance abuse in the past 6 months
  • Hospitalization for mental illness within the past year
  • High suicide risk
  • Use of psychopharmacological or psychotherapeutic treatment other than SSRIs
  • Failure to respond to two or more adequate pharmacological treatments during the current depressive episode
  • Significantly elevated blood lipids
  • Pregnancy

Treatment and study plan

SSRI + LD

Behavioral

Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.

SSRI + PHD

Behavioral

Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions.

Primary outcomes

  1. Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated)

    Time frame: 12 weeks

    The primary outcome measure- percentage of participants with remission (score of 12 or less on Inventory for Depressive Symptomatology- Clinician-rated). The change over time in probability of remission (IDS-C30 score ≤ 12) was compared between groups using a generalized linear mixed model (GLMM)41 as implemented in SAS (Proc Glimmix; SAS Institute Inc, Cary, North Carolina).

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Treatment With Exercise Augmentation for Depression (TREAD)

Acronym: TREAD

Important dates

Study start
2003
Primary completion
2006
Study completion
2007
First posted
Jan 19, 2004
Registry last updated
Sep 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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