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Adding Exercise to Antidepressant Medication Treatment for Depression (TREAD)

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ClinicalTrials.gov Identifier: NCT00076258
Recruitment Status : Completed
First Posted : January 19, 2004
Results First Posted : December 7, 2016
Last Update Posted : December 7, 2016
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Madhukar H. Trivedi, University of Texas Southwestern Medical Center

January 16, 2004
January 19, 2004
November 17, 2015
December 7, 2016
December 7, 2016
April 2003
October 2006   (Final data collection date for primary outcome measure)
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).
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Complete list of historical versions of study NCT00076258 on ClinicalTrials.gov Archive Site
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Adding Exercise to Antidepressant Medication Treatment for Depression
Treatment With Exercise Augmentation for Depression (TREAD)
This study will assess the effectiveness of an exercise program in improving antidepressant medication treatment for individuals with major depressive disorder (MDD).

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • Behavioral: SSRI + LD
    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.
  • Behavioral: SSRI + PHD
    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.
  • Experimental: SSRI+ LD
    A low dose aerobic exercise (LD) augmentation intervention to SSRI
    Intervention: Behavioral: SSRI + LD
  • Experimental: SSRI+ PHD
    A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI
    Intervention: Behavioral: SSRI + PHD

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
122
August 2007
October 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00076258
R01MH067692( U.S. NIH Grant/Contract )
R01MH067692-01 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Madhukar H. Trivedi, University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
National Institute of Mental Health (NIMH)
Principal Investigator: Madhukar Trivedi, MD UT Southwestern Medical Center
University of Texas Southwestern Medical Center
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP