Recruiting

Antidepressant

Sponsor:

California State University, San Marcos

Code:

NCT03934723

Conditions

Depression

Depressive Disorder

Metabolic Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Exercise

Study Details

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 ID

NCT03934723

Start date

Jun 15, 2019

Status verified date

Jul, 2019

Completion date

Jul, 2020

Anticipated

Primary completion date

Jul, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Exercise

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

Primary outcome measure

  • Visceral adipose tissue (VAT) [ Time Frame: Change from baseline after 6 weeks. ]
  • Waist circumference [ Time Frame: Change from baseline after 6 weeks. ]

Central Contacts and Locations

Central contacts

Dean of Graduate Studies and Research

(760) 750-4066OGSR@csusm.edu

Locations

California State University San Marcos

Recruiting

San Marcos, California, United States, 92078

Contacts

Matthew M Schubert, Ph.D.

760-750-7362mschubert@csusm.edu

Principal Investigator:

Matthew M Schubert, Ph.D.

More Information

Sponsor

California State University, San Marcos

Last update posted

Jul 23, 2019

Last verified

Jul, 2019

Keywords

  • Exercise
  • Antidepressants
  • Visceral fat

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by California State University, San Marcos on 2019-07-23.