Does Antidepressant Use Blunt Adaptations to Exercise?

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

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.

Study Overview

• Status: Unknown
• Conditions: Depressive Disorder; Depression; Metabolic Syndrome
• Intervention / Treatment: Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dean of Graduate Studies and Research; Phone Number: (760) 750-4066; Email: OGSR@csusm.edu

Study Locations

• United States
  • California
    • San Marcos, California, United States, 92078
      • Recruiting
      • California State University San Marcos
      • Contact: Matthew M Schubert, Ph.D.; Phone Number: 760-750-7362; Email: mschubert@csusm.edu
      • Principal Investigator: Matthew M Schubert, Ph.D.

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visceral adipose tissue (VAT)	VAT assessed by dual-energy X-ray absorptiometry (DXA)	Change from baseline after 6 weeks.
Waist circumference	Waist circumference is a proxy of VAT	Change from baseline after 6 weeks.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: California State University, San Marcos

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2019
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: April 26, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Exercise; Visceral fat; Antidepressants
• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Mood Disorders; Insulin Resistance; Hyperinsulinism; Depressive Disorder; Metabolic Syndrome
• Other Study ID Numbers: 1423972-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No