Trial Outcomes & Findings for Adding Exercise to Antidepressant Medication Treatment for Depression (NCT NCT00076258)
NCT ID: NCT00076258
Last Updated: 2020-09-23
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-09-23
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
64
|
|
Overall Study
COMPLETED
|
61
|
61
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adding Exercise to Antidepressant Medication Treatment for Depression
Baseline characteristics by cohort
| Measure |
SSRI+ LD
n=61 Participants
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
n=61 Participants
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
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 9.4 • n=99 Participants
|
45.6 years
STANDARD_DEVIATION 10.4 • n=107 Participants
|
47.05 years
STANDARD_DEVIATION 9.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Hamilton Depression Rating Scale (17 item)
|
18.1 units on a scale
STANDARD_DEVIATION 3.8 • n=99 Participants
|
17.8 units on a scale
STANDARD_DEVIATION 3.8 • n=107 Participants
|
17.9 units on a scale
STANDARD_DEVIATION 3.8 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksThe 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).
Outcome measures
| Measure |
SSRI+ LD
n=61 Participants
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
n=61 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Remission (Score of 12 or Less on Inventory for Depressive Symptomatology- Clinician-rated)
|
18 percentage of participants in remission
|
18 percentage of participants in remission
|
Adverse Events
SSRI+ LD
Serious events: 0 serious events
Other events: 62 other events
Deaths: 0 deaths
SSRI+ PHD
Serious events: 0 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SSRI+ LD
n=62 participants at risk
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
n=64 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea, constipation, dry mouth and Nausea
|
83.9%
52/62 • Number of events 594 • 24 months
|
85.9%
55/64 • Number of events 598 • 24 months
|
|
Cardiac disorders
Palpitation, dizzy and chest pain
|
46.8%
29/62 • Number of events 188 • 24 months
|
51.6%
33/64 • Number of events 143 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash, perspiration, itching and dry skin
|
82.3%
51/62 • Number of events 600 • 24 months
|
76.6%
49/64 • Number of events 620 • 24 months
|
|
Nervous system disorders
Headache, tremors, coordination and dizzy
|
90.3%
56/62 • Number of events 604 • 24 months
|
87.5%
56/64 • Number of events 515 • 24 months
|
|
Eye disorders
Blurred vision /ears ringing
|
58.1%
36/62 • Number of events 207 • 24 months
|
39.1%
25/64 • Number of events 288 • 24 months
|
|
Renal and urinary disorders
Difficult urination, painful urination,frequent urination and irregular menstruation
|
45.2%
28/62 • Number of events 186 • 24 months
|
43.8%
28/64 • Number of events 125 • 24 months
|
|
Psychiatric disorders
Difficulty sleeping, sleeps too much
|
93.5%
58/62 • Number of events 621 • 24 months
|
95.3%
61/64 • Number of events 532 • 24 months
|
|
Reproductive system and breast disorders
loss of desire, trouble orgasm and trouble erections
|
80.6%
50/62 • Number of events 521 • 24 months
|
62.5%
40/64 • Number of events 377 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place