Does Antidepressant Use Blunt Adaptations to Exercise?

NCT03934723 | Unknown

• 1 other identifier: 1423972-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Exercise; Antidepressants; Visceral fat

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Aerobic fitness

  Change from baseline after 6 weeks.

• Blood pressure

  Change from baseline after 6 weeks.

• Blood glucose

  Change from baseline after 6 weeks.

• Blood lipid panel

  Change from baseline after 6 weeks.

• Body mass

  Change from baseline after 6 weeks.

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Antidpressants

EXPERIMENTAL

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

Interventions

Exercise BEHAVIORAL

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

Antidpressants; Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• California State University, San Marcos: lead

Study Sites (1)

California State University San Marcos

San Marcos, California, 92078, United States

RECRUITING

MeSH Terms

Conditions

Depression; Depressive Disorder; Metabolic Syndrome; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Dean of Graduate Studies and Research

CONTACT

(760) 750-4066; OGSR@csusm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Kinesiology

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 2, 2019
• Study Start: June 15, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)