Does Antidepressant Use Blunt Adaptations to Exercise?

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StatussPieņemšana darbā

Sponsori

California State University, San Marcos

KLĪNISKĀ IZPĒTE: NCT03934723

BioSeek: nct03934723

Atslēgvārdi

Abstrakts

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.

Datumi

Pēdējoreiz pārbaudīts:	06/30/2019
Pirmais iesniegtais:	04/25/2019
Paredzētā reģistrācija iesniegta:	04/28/2019
Pirmais izlikts:	05/01/2019
Pēdējais atjauninājums iesniegts:	07/21/2019
Pēdējā atjaunināšana ievietota:	07/22/2019
Faktiskais studiju sākuma datums:	06/14/2019
Paredzamais primārās pabeigšanas datums:	06/30/2020
Paredzamais pētījuma pabeigšanas datums:	06/30/2020

Stāvoklis vai slimība

Depression

Depressive Disorder

Metabolic Syndrome

Iejaukšanās / ārstēšana

Behavioral: Exercise

Fāze

Roku grupas

Roka	Iejaukšanās / ārstēšana
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.

Atbilstības kritēriji

Vecums, kas piemērots studijām	18 Years Uz 18 Years
Dzimumi, kas ir piemēroti studijām	All
Pieņem veselīgus brīvprātīgos	Jā
Kritēriji	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.

Rezultāts

Primārie rezultāti

1. Visceral adipose tissue (VAT) [Change from baseline after 6 weeks.]

VAT assessed by dual-energy X-ray absorptiometry (DXA)

2. Waist circumference [Change from baseline after 6 weeks.]

Waist circumference is a proxy of VAT

Sekundārie iznākuma mērījumi

1. Aerobic fitness [Change from baseline after 6 weeks.]

Fitness assessed via a maximal treadmill exercise test

2. Blood pressure [Change from baseline after 6 weeks.]

Resting blood pressure assessed with an oscillatory blood pressure monitor

3. Blood glucose [Change from baseline after 6 weeks.]

Fasting capillary glucose sample

4. Blood lipid panel [Change from baseline after 6 weeks.]

Fasting capillary blood sample for triglycerides and cholesterol

5. Body mass [Change from baseline after 6 weeks.]

Body mass measured on a scale

6. Fat mass [Change from baseline after 6 weeks.]

Total and segmental body fat mass measured by DXA

7. Lean mass [Change from baseline after 6 weeks.]

Total and segmental lean mass measured by DXA

8. Dietary intake [Change from baseline after 6 weeks.]

Food logs recorded over two week days and one weekend day

9. Physical activity [Change from baseline after 6 weeks.]

Free-living physical activity assessed over 7 days via combined heart-rate and accelerometry

10. Depression symptoms [Change from baseline after 6 weeks.]

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.