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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Depression
Interventions Behavioral: SSRI + LD
Behavioral: SSRI + PHD
Enrollment 126

Recruitment Details  
Pre-assignment Details  
Arm/Group Title SSRI+ LD SSRI+ PHD
Hide Arm/Group Description

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

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.

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

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.

Period Title: Overall Study
Started 62 64
Completed 61 61
Not Completed 1 3
Arm/Group Title SSRI+ LD SSRI+ PHD Total
Hide Arm/Group Description

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

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.

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

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.

Total of all reporting groups
Overall Number of Baseline Participants 61 61 122
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 61 participants 122 participants
48.5  (9.4) 45.6  (10.4) 47.05  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 122 participants
Female
48
  78.7%
52
  85.2%
100
  82.0%
Male
13
  21.3%
9
  14.8%
22
  18.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 122 participants
Hispanic or Latino
1
   1.6%
0
   0.0%
1
   0.8%
Not Hispanic or Latino
60
  98.4%
61
 100.0%
121
  99.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 61 participants 122 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   1.6%
1
   1.6%
2
   1.6%
Black or African American
5
   8.2%
9
  14.8%
14
  11.5%
White
54
  88.5%
51
  83.6%
105
  86.1%
More than one race
1
   1.6%
0
   0.0%
1
   0.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Hamilton Depression Rating Scale (17 item)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 61 participants 61 participants 122 participants
18.1  (3.8) 17.8  (3.8) 17.9  (3.8)
[1]
Measure Description: Hamilton Depression rating scale (17 item) is a clinical interview with scores that can range from 0-52. Higher scores indicate higher levels of depression symptoms.
1.Primary Outcome
Title Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated)
Hide Description 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).
Time Frame 12 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SSRI+ LD SSRI+ PHD
Hide Arm/Group Description:

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

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.

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

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.

Overall Number of Participants Analyzed 61 61
Measure Type: Number
Unit of Measure: percentage of participants in remission
18 18
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SSRI+ LD, SSRI+ PHD
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Generalized Linear Mixed Model
Comments Both unadjusted and adjusted rates (for significant covariates) were reported
Method of Estimation Estimation Parameter Remission rate
Estimated Value 29.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SSRI+ LD, SSRI+ PHD
Comments For the covariate adjusted GLMM the remission rates were 15.5 for the LD and 28.3 for the PHD with a p < 0.06 and the NNT of 7.8 for the PHD versus the LD.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Generalized Linear Mixed Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Remission Rate
Estimated Value 28.3
Estimation Comments [Not Specified]
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SSRI+ LD SSRI+ PHD
Hide Arm/Group Description

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

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.

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

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.

All-Cause Mortality
SSRI+ LD SSRI+ PHD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SSRI+ LD SSRI+ PHD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/62 (0.00%)      0/64 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SSRI+ LD SSRI+ PHD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   62/62 (100.00%)      64/64 (100.00%)    
Cardiac disorders     
Palpitation, dizzy and chest pain  [1]  29/62 (46.77%)  188 33/64 (51.56%)  143
Eye disorders     
Blurred vision /ears ringing  [1]  36/62 (58.06%)  207 25/64 (39.06%)  288
Gastrointestinal disorders     
Diarrhea, constipation, dry mouth and Nausea  [1]  52/62 (83.87%)  594 55/64 (85.94%)  598
Nervous system disorders     
Headache, tremors, coordination and dizzy  [1]  56/62 (90.32%)  604 56/64 (87.50%)  515
Psychiatric disorders     
Difficulty sleeping, sleeps too much  [1]  58/62 (93.55%)  621 61/64 (95.31%)  532
Renal and urinary disorders     
Difficult urination, painful urination,frequent urination and irregular menstruation  [1]  28/62 (45.16%)  186 28/64 (43.75%)  125
Reproductive system and breast disorders     
loss of desire, trouble orgasm and trouble erections  [1]  50/62 (80.65%)  521 40/64 (62.50%)  377
Skin and subcutaneous tissue disorders     
Rash, perspiration, itching and dry skin  [1]  51/62 (82.26%)  600 49/64 (76.56%)  620
Indicates events were collected by systematic assessment
[1]
Specific adverse event terms are unknown because adverse events were only collected with regard to the affected organ system.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Madhukar H Trivedi
Organization: UT Southwestern Medical Center
Phone: 214-648-0188
Responsible Party: Madhukar H. Trivedi, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00076258     History of Changes
Other Study ID Numbers: R01MH067692 ( U.S. NIH Grant/Contract )
R01MH067692-01 ( U.S. NIH Grant/Contract )
First Submitted: January 16, 2004
First Posted: January 19, 2004
Results First Submitted: November 17, 2015
Results First Posted: December 7, 2016
Last Update Posted: December 7, 2016