Does Antidepressant Use Blunt Adaptations to Exercise?

• ClinicalTrials.gov Identifier: NCT03934723
• Recruitment Status: Unknown
• First Posted: May 2, 2019
• Last Update Posted: July 23, 2019
• Sponsor: California State University, San Marcos
• Information provided by (Responsible Party): Matthew Schubert, California State University, San Marcos

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.

Condition or disease	Intervention/treatment	Phase
Depression; Depressive Disorder; Metabolic Syndrome	Behavioral: Exercise	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Do Antidepressant Medications Blunt Responses to Exercise Training in Overweight and Obese Individuals?
• Actual Study Start Date: June 15, 2019
• Estimated Primary Completion Date: July 2020
• Estimated Study Completion Date: July 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Control; This arm will consist of healthy overweight and obese individuals who are physically inactive and do not have clinically diagnosed depression or depression symptoms.	Behavioral: Exercise; The intervention consists of 180 minutes of moderate-vigorous aerobic exercise per week for 6 weeks.
Experimental: Antidpressants; 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.	Behavioral: Exercise; The intervention consists of 180 minutes of moderate-vigorous aerobic exercise per week for 6 weeks.

Outcome Measures

Primary Outcome Measures :

1. Visceral adipose tissue (VAT) [ Time Frame: Change from baseline after 6 weeks. ]
   VAT assessed by dual-energy X-ray absorptiometry (DXA)
2. Waist circumference [ Time Frame: Change from baseline after 6 weeks. ]
   Waist circumference is a proxy of VAT

Secondary Outcome Measures :

1. Aerobic fitness [ Time Frame: Change from baseline after 6 weeks. ]
   Fitness assessed via a maximal treadmill exercise test
2. Blood pressure [ Time Frame: Change from baseline after 6 weeks. ]
   Resting blood pressure assessed with an oscillatory blood pressure monitor
3. Blood glucose [ Time Frame: Change from baseline after 6 weeks. ]
   Fasting capillary glucose sample
4. Blood lipid panel [ Time Frame: Change from baseline after 6 weeks. ]
   Fasting capillary blood sample for triglycerides and cholesterol
5. Body mass [ Time Frame: Change from baseline after 6 weeks. ]
   Body mass measured on a scale
6. Fat mass [ Time Frame: Change from baseline after 6 weeks. ]
   Total and segmental body fat mass measured by DXA
7. Lean mass [ Time Frame: Change from baseline after 6 weeks. ]
   Total and segmental lean mass measured by DXA
8. Dietary intake [ Time Frame: Change from baseline after 6 weeks. ]
   Food logs recorded over two week days and one weekend day
9. Physical activity [ Time Frame: Change from baseline after 6 weeks. ]
   Free-living physical activity assessed over 7 days via combined heart-rate and accelerometry
10. Depression symptoms [ Time Frame: Change from baseline after 6 weeks. ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

Contact: Dean of Graduate Studies and Research; (760) 750-4066; OGSR@csusm.edu

Locations

United States, California

California State University San Marcos; Recruiting

San Marcos, California, United States, 92078

Contact: Matthew M Schubert, Ph.D. 760-750-7362 mschubert@csusm.edu

Principal Investigator: Matthew M Schubert, Ph.D.

Sponsors and Collaborators

California State University, San Marcos

More Information

• Responsible Party: Matthew Schubert, Assistant Professor of Kinesiology, California State University, San Marcos
• ClinicalTrials.gov Identifier: NCT03934723
• Other Study ID Numbers: 1423972-1
• First Posted: May 2, 2019
• Last Update Posted: July 23, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matthew Schubert, California State University, San Marcos:

Exercise; Antidepressants; Visceral fat

Additional relevant MeSH terms:

Metabolic Syndrome; Depressive Disorder; Mood Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases