CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 126 enrolled
Drug / intervention
SSRI + LD +1 morebehavioral
Likely dose
Low dose aerobic exercise (LD) or public health dose aerobic exercise (PHD) for 24 weeks, added to ongoing SSRIAI-extracted
Key inclusion· 6
  • ✓Confirmed diagnosis of Major Depressive Disorder
  • ✓HAM-D score ≥14 at screening
  • ✓8–12 weeks of SSRI treatment with at least 6 weeks at adequate doses
  • ✓Sedentary lifestyle
Key exclusion· 12
  • ✕Significant cardiovascular disease or other serious medical conditions precluding exercise
  • ✕Uncontrolled hypertension
  • ✕Abnormal result on exercise stress test
  • ✕Hematologic disorders

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT00076258N/ACompleted
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Treatment With Exercise Augmentation for Depression (TREAD)

University of Texas Southwestern Medical Center·interventional·Posted Jan 19, 2004·Updated Sep 23, 2020

In Brief

A clinical study evaluating SSRI + LD and SSRI + PHD for Depression. Completed, enrolled 126 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 19, 2004
Enrollment StartApr 1, 2003
Primary CompletionOct 1, 2006
Study CompletionAug 1, 2007
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 22.5 years ago

Interventions

SSRI + LDbehavioral

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 + PHDbehavioral

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.