Does Antidepressant Use Blunt Adaptations to Exercise?

Depression Clinical Trial

Official title:

Do Antidepressant Medications Blunt Responses to Exercise Training in Overweight and Obese Individuals?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03934723
• Other study ID #: 1423972-1
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2019
• Est. completion date: July 2020

Study information

• Verified date: July 2019
• Source: California State University, San Marcos
• Contact: Dean of Graduate Studies and Research
• Phone: (760) 750-4066
• Email: OGSR[@]csusm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Metabolic Syndrome

Intervention

Behavioral:
• Exercise
The intervention consists of 180 minutes of moderate-vigorous aerobic exercise per week for 6 weeks.

Locations

Country	Name	City	State
United States	California State University San Marcos	San Marcos	California

Sponsors (1)

Lead Sponsor	Collaborator
California State University, San Marcos

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visceral adipose tissue (VAT)	VAT assessed by dual-energy X-ray absorptiometry (DXA)	Change from baseline after 6 weeks.
Primary	Waist circumference	Waist circumference is a proxy of VAT	Change from baseline after 6 weeks.
Secondary	Aerobic fitness	Fitness assessed via a maximal treadmill exercise test	Change from baseline after 6 weeks.
Secondary	Blood pressure	Resting blood pressure assessed with an oscillatory blood pressure monitor	Change from baseline after 6 weeks.
Secondary	Blood glucose	Fasting capillary glucose sample	Change from baseline after 6 weeks.
Secondary	Blood lipid panel	Fasting capillary blood sample for triglycerides and cholesterol	Change from baseline after 6 weeks.
Secondary	Body mass	Body mass measured on a scale	Change from baseline after 6 weeks.
Secondary	Fat mass	Total and segmental body fat mass measured by DXA	Change from baseline after 6 weeks.
Secondary	Lean mass	Total and segmental lean mass measured by DXA	Change from baseline after 6 weeks.
Secondary	Dietary intake	Food logs recorded over two week days and one weekend day	Change from baseline after 6 weeks.
Secondary	Physical activity	Free-living physical activity assessed over 7 days via combined heart-rate and accelerometry	Change from baseline after 6 weeks.
Secondary	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.	Change from baseline after 6 weeks.