Does Antidepressant Use Blunt Adaptations to Exercise?

NCT ID: NCT03934723

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2020-07-31

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.

Conditions

Depression; Depressive Disorder; Metabolic Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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

Interventions

Exercise

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

California State University, San Marcos

OTHER

Sponsor Role: lead

Responsible Party

Matthew Schubert

Assistant Professor of Kinesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

California State University San Marcos

San Marcos, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dean of Graduate Studies and Research

Role: CONTACT

OGSR@csusm.edu

(760) 750-4066

Facility Contacts

Matthew M Schubert, Ph.D.

Role: primary

mschubert@csusm.edu

760-750-7362

Other Identifiers

1423972-1

Identifier Type: -

Identifier Source: org_study_id