Treatment With Exercise Augmentation for Depression (TREAD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated)
Study Overview
Brief Summary
This study will assess the effectiveness of an exercise program in improving antidepressant medication treatment for individuals with major depressive disorder (MDD).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
SSRI+ LD
A low dose aerobic exercise (LD) augmentation intervention to SSRI
Intervention: SSRI + LD (Behavioral)
SSRI+ PHD
A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI
Intervention: SSRI + PHD (Behavioral)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Madhukar H. Trivedi, MD
Professor of Psychiatry
University of Texas Southwestern Medical Center