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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
SSRI+ LD

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.

SSRI+ PHD

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.


Participant Flow:   Overall Study
    SSRI+ LD   SSRI+ PHD
STARTED   62   64 
COMPLETED   61   61 
NOT COMPLETED   1   3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
SSRI+ LD

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.

SSRI+ PHD

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 Total of all reporting groups

Baseline Measures
   SSRI+ LD   SSRI+ PHD   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   61   122 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.5  (9.4)   45.6  (10.4)   47.05  (9.9) 
Gender 
[Units: Participants]
     
Female   48   52   100 
Male   13   9   22 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   1   0   1 
Not Hispanic or Latino   60   61   121 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   1   1   2 
Black or African American   5   9   14 
White   54   51   105 
More than one race   1   0   1 
Unknown or Not Reported   0   0   0 
Hamilton Depression Rating Scale (17 item) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 18.1  (3.8)   17.8  (3.8)   17.9  (3.8) 


  Outcome Measures

1.  Primary:   Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated)   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: madhukar.trivedi@utsouthwestern.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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