Clinical trial NCT03934723: Does Antidepressant Use Blunt Adaptations to Exercise?
Official title: Do Antidepressant Medications Blunt Responses to Exercise Training in Overweight and Obese Individuals?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Depressive Disorder
Metabolic Syndrome
Keywords: Exercise
Antidepressants
Visceral fat
Lead sponsor: California State University, San Marcos
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Visceral adipose tissue (VAT)
timeFrame: Change from baseline after 6 weeks.
measure: Waist circumference
timeFrame: Change from baseline after 6 weeks.
Secondary outcomes:
measure: Aerobic fitness
timeFrame: Change from baseline after 6 weeks.
measure: Blood pressure
timeFrame: Change from baseline after 6 weeks.
measure: Blood glucose
timeFrame: Change from baseline after 6 weeks.
measure: Blood lipid panel
timeFrame: Change from baseline after 6 weeks.
measure: Body mass
timeFrame: Change from baseline after 6 weeks.
measure: Fat mass
timeFrame: Change from baseline after 6 weeks.
measure: Lean mass
timeFrame: Change from baseline after 6 weeks.
measure: Dietary intake
timeFrame: Change from baseline after 6 weeks.
measure: Physical activity
timeFrame: Change from baseline after 6 weeks.
measure: Depression symptoms
timeFrame: Change from baseline after 6 weeks.
Other outcomes:
Locations:
city: San Marcos
country: United States
facility: California State University San Marcos
state: California
Study officials:
References: