An interventional study of Exercise in Depression, Depressive Disorder and Metabolic Syndrome, sponsored by California State University, San Marcos. Status unknown at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-23.
Sponsored by California State University, San Marcos · Not applicable, Interventional, and Treatment
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 24 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →California State University, San Marcos is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Visceral adipose tissue (VAT)
VAT assessed by dual-energy X-ray absorptiometry (DXA)
Time frame: Change from baseline after 6 weeks.
Waist circumference
Waist circumference is a proxy of VAT
Time frame: Change from baseline after 6 weeks.
Aerobic fitness
Fitness assessed via a maximal treadmill exercise test
Time frame: Change from baseline after 6 weeks.
Blood pressure
Resting blood pressure assessed with an oscillatory blood pressure monitor
Time frame: Change from baseline after 6 weeks.
Blood glucose
Fasting capillary glucose sample
Time frame: Change from baseline after 6 weeks.
Blood lipid panel
Fasting capillary blood sample for triglycerides and cholesterol
Time frame: Change from baseline after 6 weeks.
Body mass
Body mass measured on a scale
Time frame: Change from baseline after 6 weeks.
Fat mass
Total and segmental body fat mass measured by DXA
Time frame: Change from baseline after 6 weeks.
Lean mass
Total and segmental lean mass measured by DXA
Time frame: Change from baseline after 6 weeks.
Dietary intake
Food logs recorded over two week days and one weekend day
Time frame: Change from baseline after 6 weeks.
Physical activity
Free-living physical activity assessed over 7 days via combined heart-rate and accelerometry
Time frame: 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.
Time frame: Change from baseline after 6 weeks.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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California State University, San Marcos