Does Antidepressant Use Blunt Adaptations to Exercise?
Primary Purpose
Depression, Depressive Disorder, Metabolic Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Exercise, Antidepressants, Visceral fat
Eligibility Criteria
Inclusion Criteria:
- Participants will be English language speakers
- Male or females between the ages of 18-40.
- All genders and ethnicities.
- Healthy as assessed by a health history questionnaire (no diagnosed physical diseases or conditions preventing participation in exercise).
- Individuals on antidepressants will be recruited if they are consuming selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and norepinephrine reuptake inhibitors (SNRIs) only. Participants will send prescription information after consent has been provided as part of the screening process, including the dose and frequency of medication.
- A body mass index (BMI) of 25 or greater is required for inclusion.
Exclusion Criteria:
- Inability to complete moderate-vigorous exercise.
- Taking first generation antidepressant medications or other medications such as monoamine oxidase inhibitors (MAOI).
- Other medications, such as medications for attention-deficit hyper-activity disorder or metabolism
- Undiagnosed depression that may be unveiled during the screening process.
Sites / Locations
- California State University San MarcosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Antidpressants
Arm Description
This arm will consist of healthy overweight and obese individuals who are physically inactive and do not have clinically diagnosed depression or depression symptoms.
This arm will consist of healthy overweight and obese adults who are physically inactive and who are diagnosed with clinical depression and have been taking antidepressant medications for at least 1 year.
Outcomes
Primary Outcome Measures
Visceral adipose tissue (VAT)
VAT assessed by dual-energy X-ray absorptiometry (DXA)
Waist circumference
Waist circumference is a proxy of VAT
Secondary Outcome Measures
Aerobic fitness
Fitness assessed via a maximal treadmill exercise test
Blood pressure
Resting blood pressure assessed with an oscillatory blood pressure monitor
Blood glucose
Fasting capillary glucose sample
Blood lipid panel
Fasting capillary blood sample for triglycerides and cholesterol
Body mass
Body mass measured on a scale
Fat mass
Total and segmental body fat mass measured by DXA
Lean mass
Total and segmental lean mass measured by DXA
Dietary intake
Food logs recorded over two week days and one weekend day
Physical activity
Free-living physical activity assessed over 7 days via combined heart-rate and accelerometry
Depression symptoms
Symptoms of depression assessed with Beck's Depression Inventory (BDI). The BDI is a 21-item questionnaire that measures total depressive symptoms. Individual item scores range from 0-3. Individual items are then summed to provide a total score, ranging from 0 to 63.
Full Information
NCT ID
NCT03934723
First Posted
April 26, 2019
Last Updated
July 22, 2019
Sponsor
California State University, San Marcos
1. Study Identification
Unique Protocol Identification Number
NCT03934723
Brief Title
Does Antidepressant Use Blunt Adaptations to Exercise?
Official Title
Do Antidepressant Medications Blunt Responses to Exercise Training in Overweight and Obese Individuals?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California State University, San Marcos
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Nearly one out of ten US adults over the age of 18 currently takes antidepressant medication, which can also treat other conditions such as anxiety. Combining pharmaceutical treatment with exercise may yield even greater benefits than using drugs alone, and this is commonly prescribed for depression. However, little is known about the drug-exercise interactions and their influence on metabolic health. A common side effect of antidepressant use is weight gain, particularly abdominal (visceral) fat, which is highly detrimental to overall health. Exercise is a well-known counter to abdominal fat accumulation. The aim of the proposed study is to compare the efficacy of 6 weeks of exercise training to reduce abdominal fat in healthy overweight/obese adults either taking or not taking antidepressant medication. Twenty-four inactive overweight/obese, but otherwise healthy, adults will complete 6 weeks of an exercise training intervention consisting of three days of aerobic exercise training per week. Participants will either not be taking antidepressant medication or will have been on their medication for at least 1 year. The primary outcome will be abdominal fat determined by waist circumference and dual x-ray absorptiometry, which is considered one of the optimal methods for assessment of abdominal fat.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder, Metabolic Syndrome
Keywords
Exercise, Antidepressants, Visceral fat
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
This arm will consist of healthy overweight and obese individuals who are physically inactive and do not have clinically diagnosed depression or depression symptoms.
Arm Title
Antidpressants
Arm Type
Experimental
Arm Description
This arm will consist of healthy overweight and obese adults who are physically inactive and who are diagnosed with clinical depression and have been taking antidepressant medications for at least 1 year.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
The intervention consists of 180 minutes of moderate-vigorous aerobic exercise per week for 6 weeks.
Primary Outcome Measure Information:
Title
Visceral adipose tissue (VAT)
Description
VAT assessed by dual-energy X-ray absorptiometry (DXA)
Time Frame
Change from baseline after 6 weeks.
Title
Waist circumference
Description
Waist circumference is a proxy of VAT
Time Frame
Change from baseline after 6 weeks.
Secondary Outcome Measure Information:
Title
Aerobic fitness
Description
Fitness assessed via a maximal treadmill exercise test
Time Frame
Change from baseline after 6 weeks.
Title
Blood pressure
Description
Resting blood pressure assessed with an oscillatory blood pressure monitor
Time Frame
Change from baseline after 6 weeks.
Title
Blood glucose
Description
Fasting capillary glucose sample
Time Frame
Change from baseline after 6 weeks.
Title
Blood lipid panel
Description
Fasting capillary blood sample for triglycerides and cholesterol
Time Frame
Change from baseline after 6 weeks.
Title
Body mass
Description
Body mass measured on a scale
Time Frame
Change from baseline after 6 weeks.
Title
Fat mass
Description
Total and segmental body fat mass measured by DXA
Time Frame
Change from baseline after 6 weeks.
Title
Lean mass
Description
Total and segmental lean mass measured by DXA
Time Frame
Change from baseline after 6 weeks.
Title
Dietary intake
Description
Food logs recorded over two week days and one weekend day
Time Frame
Change from baseline after 6 weeks.
Title
Physical activity
Description
Free-living physical activity assessed over 7 days via combined heart-rate and accelerometry
Time Frame
Change from baseline after 6 weeks.
Title
Depression symptoms
Description
Symptoms of depression assessed with Beck's Depression Inventory (BDI). The BDI is a 21-item questionnaire that measures total depressive symptoms. Individual item scores range from 0-3. Individual items are then summed to provide a total score, ranging from 0 to 63.
Time Frame
Change from baseline after 6 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants will be English language speakers
Male or females between the ages of 18-40.
All genders and ethnicities.
Healthy as assessed by a health history questionnaire (no diagnosed physical diseases or conditions preventing participation in exercise).
Individuals on antidepressants will be recruited if they are consuming selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and norepinephrine reuptake inhibitors (SNRIs) only. Participants will send prescription information after consent has been provided as part of the screening process, including the dose and frequency of medication.
A body mass index (BMI) of 25 or greater is required for inclusion.
Exclusion Criteria:
Inability to complete moderate-vigorous exercise.
Taking first generation antidepressant medications or other medications such as monoamine oxidase inhibitors (MAOI).
Other medications, such as medications for attention-deficit hyper-activity disorder or metabolism
Undiagnosed depression that may be unveiled during the screening process.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dean of Graduate Studies and Research
Phone
(760) 750-4066
Email
OGSR@csusm.edu
Facility Information:
Facility Name
California State University San Marcos
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew M Schubert, Ph.D.
Phone
760-750-7362
Email
mschubert@csusm.edu
First Name & Middle Initial & Last Name & Degree
Matthew M Schubert, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
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Does Antidepressant Use Blunt Adaptations to Exercise?
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