DepressionNCT03934723
Does Antidepressant Use Blunt Adaptations to Exercise?
A study testing Exercise in people with Depression and Depressive Disorder, run by California State University, San Marcos at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Depressive Disorder, Metabolic Syndrome
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2019to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
California State University San Marcos
San Marcos, California, 92078
Matthew M Schubert, Ph.D., 760-750-7362, mschubert@csusm.edu
Matthew M Schubert, Ph.D.
About this study
Official title: Do Antidepressant Medications Blunt Responses to Exercise Training in Overweight and Obese Individuals?
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
- Being tested
- Exercise
- Keywords
- Exercise, Antidepressants, Visceral fat
- Medical subject headings
- Depression, Depressive Disorder, Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
The intervention consists of 180 minutes of moderate-vigorous aerobic exercise per week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | This arm will consist of healthy overweight and obese individuals who are physically inactive and do not have clinically diagnosed depression or depression symptoms. Receives: Behavioral: Exercise |
| Antidpressants | Experimental | 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. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visceral adipose tissue (VAT)
VAT assessed by dual-energy X-ray absorptiometry (DXA)
Measured: Change from baseline after 6 weeks.
Waist circumference
Waist circumference is a proxy of VAT
Measured: Change from baseline after 6 weeks.
Secondary outcomes (10)
Aerobic fitness
Fitness assessed via a maximal treadmill exercise test
Measured: Change from baseline after 6 weeks.
Blood pressure
Resting blood pressure assessed with an oscillatory blood pressure monitor
Measured: Change from baseline after 6 weeks.
Blood glucose
Fasting capillary glucose sample
Measured: Change from baseline after 6 weeks.
Blood lipid panel
Fasting capillary blood sample for triglycerides and cholesterol
Measured: Change from baseline after 6 weeks.
Body mass
Body mass measured on a scale
Measured: Change from baseline after 6 weeks.
Fat mass
Total and segmental body fat mass measured by DXA
Measured: Change from baseline after 6 weeks.
Lean mass
Total and segmental lean mass measured by DXA
Measured: Change from baseline after 6 weeks.
Dietary intake
Food logs recorded over two week days and one weekend day
Measured: Change from baseline after 6 weeks.
Physical activity
Free-living physical activity assessed over 7 days via combined heart-rate and accelerometry
Measured: 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.
Measured: Change from baseline after 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start15 Jun 2019
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California State University, San Marcos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Schubert, California State University, San Marcos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934723
- Sponsor's protocol ID
- 1423972-1
- Status last verified
- Jul 2019
- First submitted
- 26 Apr 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Antidepressant Medications Blunt Responses to Exercise Training in Overweight and Obese Individuals?
- ClinicalTrials.gov ID
- NCT03934723
- Acronym / sponsor ID
- 1423972-1
- Conditions
- Depression, Depressive Disorder, Metabolic Syndrome
- Keywords
- Exercise, Antidepressants, Visceral fat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- California State University, San MarcosUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ExerciseThis arm will consist of healthy overweight and obese individuals who are physically inactive and do not have clinically diagnosed depression or depression symptoms. |
| Antidpressants | Experimental | Behavioral: ExerciseThis 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe intervention consists of 180 minutes of moderate-vigorous aerobic exercise per week for 6 weeks. | Behavioural | Antidpressants, Control |
Primary outcome
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
10 secondary outcomes
Aerobic fitness
Time frame: Change from baseline after 6 weeks.
Blood pressure
Time frame: Change from baseline after 6 weeks.
Blood glucose
Time frame: Change from baseline after 6 weeks.
Blood lipid panel
Time frame: Change from baseline after 6 weeks.
Body mass
Time frame: Change from baseline after 6 weeks.
Fat mass
Time frame: Change from baseline after 6 weeks.
Lean mass
Time frame: Change from baseline after 6 weeks.
Dietary intake
Time frame: Change from baseline after 6 weeks.
Physical activity
Time frame: Change from baseline after 6 weeks.
Depression symptoms
Time frame: Change from baseline after 6 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Depression
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
Recruiting
Teenthrive 2: Treatments for Improving Mood in Teens
Depression in Adolescence
Active, not recruiting
Developing and Testing an Online Pathway From Screening to Treatment for Depression in Oncology: iPath*D (Aim 2)
Cancer, Depression
RecruitingPhase 2
Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
Major Depressive Disorder (MDD), Alcohol Use Disorder (AUD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Depression and Depressive Disorder, run by California State University, San Marcos at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dean of Graduate Studies and Research ((760) 750-4066, OGSR@csusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visceral adipose tissue (VAT) (time frame: Change from baseline after 6 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.