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Does Antidepressant Use Blunt Adaptations to Exercise?

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ClinicalTrials.gov Identifier: NCT03934723
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Schubert, California State University, San Marcos

Tracking Information
First Submitted Date  ICMJE April 26, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date July 23, 2019
Actual Study Start Date  ICMJE June 15, 2019
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • Visceral adipose tissue (VAT) [ Time Frame: Change from baseline after 6 weeks. ]
    VAT assessed by dual-energy X-ray absorptiometry (DXA)
  • Waist circumference [ Time Frame: Change from baseline after 6 weeks. ]
    Waist circumference is a proxy of VAT
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03934723 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2019)
  • Aerobic fitness [ Time Frame: Change from baseline after 6 weeks. ]
    Fitness assessed via a maximal treadmill exercise test
  • Blood pressure [ Time Frame: Change from baseline after 6 weeks. ]
    Resting blood pressure assessed with an oscillatory blood pressure monitor
  • Blood glucose [ Time Frame: Change from baseline after 6 weeks. ]
    Fasting capillary glucose sample
  • Blood lipid panel [ Time Frame: Change from baseline after 6 weeks. ]
    Fasting capillary blood sample for triglycerides and cholesterol
  • Body mass [ Time Frame: Change from baseline after 6 weeks. ]
    Body mass measured on a scale
  • Fat mass [ Time Frame: Change from baseline after 6 weeks. ]
    Total and segmental body fat mass measured by DXA
  • Lean mass [ Time Frame: Change from baseline after 6 weeks. ]
    Total and segmental lean mass measured by DXA
  • Dietary intake [ Time Frame: Change from baseline after 6 weeks. ]
    Food logs recorded over two week days and one weekend day
  • Physical activity [ Time Frame: Change from baseline after 6 weeks. ]
    Free-living physical activity assessed over 7 days via combined heart-rate and accelerometry
  • Depression symptoms [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • Aerobic fitness [ Time Frame: Change from baseline after 6 weeks. ]
    Fitness assessed via a maximal treadmill exercise test
  • Blood pressure [ Time Frame: Change from baseline after 6 weeks. ]
    Resting blood pressure assessed with an oscillatory blood pressure monitor
  • Blood glucose [ Time Frame: Change from baseline after 6 weeks. ]
    Fasting capillary glucose sample
  • Blood lipid panel [ Time Frame: Change from baseline after 6 weeks. ]
    Fasting capillary blood sample for triglycerides and cholesterol
  • Body mass [ Time Frame: Change from baseline after 6 weeks. ]
    Body mass measured on a scale
  • Fat mass [ Time Frame: Change from baseline after 6 weeks. ]
    Total and segmental body fat mass measured by DXA
  • Lean mass [ Time Frame: Change from baseline after 6 weeks. ]
    Total and segmental lean mass measured by DXA
  • Dietary intake [ Time Frame: Change from baseline after 6 weeks. ]
    Food logs recorded over two week days and one weekend day
  • Physical activity [ Time Frame: Change from baseline after 6 weeks. ]
    Free-living physical activity assessed over 7 days via combined heart-rate and accelerometry
  • Depression symptoms [ Time Frame: Change from baseline after 6 weeks. ]
    Symptoms of depression assessed with Beck's Depression Inventory
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Antidepressant Use Blunt Adaptations to Exercise?
Official Title  ICMJE Do Antidepressant Medications Blunt Responses to Exercise Training in Overweight and Obese Individuals?
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Depressive Disorder
  • Metabolic Syndrome
Intervention  ICMJE Behavioral: Exercise
The intervention consists of 180 minutes of moderate-vigorous aerobic exercise per week for 6 weeks.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Exercise
  • 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.
    Intervention: Behavioral: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 29, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Dean of Graduate Studies and Research (760) 750-4066 OGSR@csusm.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03934723
Other Study ID Numbers  ICMJE 1423972-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Matthew Schubert, California State University, San Marcos
Study Sponsor  ICMJE California State University, San Marcos
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account California State University, San Marcos
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP