DepressionNCT06805851
Impact of Depression on Thermoregulation
An observational study of Depression and Selective Serotonin Reuptake Inhibitor, run by Penn State University at 1 site in United States.
Trial summary
The purpose of this study is to determine if, compared to non-depressed adults, differences exist in skin blood flow and sweating responses to passive heat stress in adults with clinically diagnosed depression, those with depression who are prescribed and taking SSRIs and those with depression who are prescribed and… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Selective Serotonin Reuptake Inhibitor
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 30 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Participants will be recruited from Centre County Pennsylvania including on the Penn State University campus.
Who may be able to join
- Non-depressed adults aged 18-40 years;
- OR adults aged 18-40 years with clinically diagnosed major depressive disorder according to DSM-V criteria not currently receiving antidepressant treatment;
- OR adults aged 18-40 years with clinically diagnosed major depressive disorder with at least 2 weeks of treatment with a selective serotonin reuptake inhibitor;
- OR aged 18-40 years adults with clinically diagnosed major depressive disorder with at least 2 weeks of treatment with a serotonin norepinephrine reuptake inhibitor;
- All participants will be asymptomatic and no signs/symptoms of disease according to the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription (chest pain or pressure, dizziness, joint pain, and signs of cardiovascular disease);
- Systolic blood pressure 140 mmHg and diastolic pressure 90 mmHg at screening;
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- Non-diabetic
- Not taking any other medications that might affect the physiological variables of interest (beta blockers, tricyclic antidepressants, antipyretics, diuretics, etc.);;
- Between the 20th and 80th percentiles for sex- and age-appropriate VO2max according to the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription;
- English proficiency;
- Capable of providing informed consent.
Who cannot join
- BMI > 35
- Are pregnant or planning to become pregnant in the next 12 months;
- Concurrently participate in another study involving physical activity or weight loss;
- Plan to have surgery or relocate outside the area within the next year;
- Medications that could alter cardiovascular or thermoregulatory responses to exercise (beta blockers, antipyretics, tricyclic antidepressants, diuretics, etc.);
- Allergy to latex or adhesive;
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- Tobacco use;
- Illegal/recreational drug use;
- Exertional chest pain or musculoskeletal pain;
- Contraindications to a maximal exercise test or an indication for early termination of the exercise test according to the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription;
- Abnormal resting or exercise electrocardiogram (ECG);
- Any bleeding disorders, gastric ulcers, allergies to NSAIDS, asthma, kidney/liver disorders, and taking any other anticoagulants;
- History of Crohn's disease, diverticulitis, or similar gastrointestinal disease;
- Co-morbid psychiatric disorders (psychosis, schizophrenia, bipolar disorder, panic disorder, obsessive compulsive disorder, etc.);
- Active suicidal ideation (moderate or high suicidality);
- Use of psychoactive or psychopharmacological drugs other than SSRI and SNRIs within one year of participating.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Noll Laboratory
University Park, Pennsylvania, 16802
Kat Fisher, 3072037657, kgf5118@psu.edu
About this study
Official title: Thermoregulatory Responses to Heat Stress in Adults With Major Depressive Disorder With and Without Antidepressant Treatment
The purpose of this study is to determine if, compared to non-depressed adults, differences exist in skin blood flow and sweating responses to passive heat stress in adults with clinically diagnosed depression, those with depression who are prescribed and taking SSRIs and those with depression who are prescribed and taking SNRIs.
Read the detailed description
Four groups will be recruited to examine the impact of major depressive disorder and pharmaceutical treatments on thermoregulatory heat loss mechanisms. Adults without MDD, adults with MDD, adults with MDD currently prescribed and taking selective serotonin reuptake inhibitors as treatment, and adults with MDD currently prescribed and taking serotonin norepinephrine reuptake inhibitors as treatment will be recruited to completed a passive heat stress experiment. All subjects will sign an informed consent form and undergo a medical screening prior to participation. Each subject will complete 1 passive heat stress experiment in which body temperature will be using a water perfused suit. During passive heating, body temperature, skin blood flow, and local and whole-body sweat rates will be continuously measured and recorded to compare heat stress responses between groups.
- Conditions
- Depression, Selective Serotonin Reuptake Inhibitor
- Keywords
- thermoregulation, heat stress, depression, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors
- Medical subject headings
- Depression, Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-depressed | Not described | |
| Depressed | adults with clinically diagnosed major depressive disorder | |
| SSRI | adults with clinically diagnosed major depressive disorder currently taking a physician prescribed selective serotonin reuptake inhibitor as treatment. | |
| SNRI | adults with clinically diagnosed major depressive disorder currently taking a physician prescribed serotonin norepinephrine reuptake inhibitor as treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin blood flow
Skin blood flow response to whole body heating is continuously monitored during the experimental trial, about 2 hours.
Measured: Monitored continuously during the passive heating experimental trial, about 2 hours.
Local Sweat Rate
A small sweat capsule is placed on the forearm for the duration of the passive whole body heating experiment, about 2 hours.
Measured: Monitored continuously during the passive heating experimental trial, about 2 hours.
Core Temperature
Changes in body temperature are measured through a telemetry pill swallowed before each experiment.
Measured: Monitored continuously during the passive heating experimental trial, about 2 hours.
Secondary outcomes (1)
Body Mass
Body mass is measured on a scale before and after the passive heating experimental trail.
Measured: Will be measured once immediately before and once immediately after the passive heating experimental trail.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 Mar 2025
- Primary completion1 Dec 2025
- Study completion30 Jan 2027 (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.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W. Larry Kenney, Penn State University
- Investigators
- W. Larry Kenney, Principal investigator, The Pennsylvania State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805851
- Sponsor's protocol ID
- Study26326
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermoregulatory Responses to Heat Stress in Adults With Major Depressive Disorder With and Without Antidepressant Treatment
- ClinicalTrials.gov ID
- NCT06805851
- Acronym / sponsor ID
- Study26326
- Conditions
- Depression, Selective Serotonin Reuptake Inhibitor
- Keywords
- thermoregulation, heat stress, depression, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 3 Feb 2025 (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.
The purpose of this study is to determine if, compared to non-depressed adults, differences exist in skin blood flow and sweating responses to passive heat stress in adults with clinically diagnosed depression, those with depression who are prescribed and taking SSRIs and those with depression who are prescribed and taking SNRIs.
Detailed description
Four groups will be recruited to examine the impact of major depressive disorder and pharmaceutical treatments on thermoregulatory heat loss mechanisms. Adults without MDD, adults with MDD, adults with MDD currently prescribed and taking selective serotonin reuptake inhibitors as treatment, and adults with MDD currently prescribed and taking serotonin norepinephrine reuptake inhibitors as treatment will be recruited to completed a passive heat stress experiment. All subjects will sign an informed consent form and undergo a medical screening prior to participation. Each subject will complete 1 passive heat stress experiment in which body temperature will be using a water perfused suit. During passive heating, body temperature, skin blood flow, and local and whole-body sweat rates will be continuously measured and recorded to compare heat stress responses between groups.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-depressed | – | – |
| Depressed | – | –adults with clinically diagnosed major depressive disorder |
| SSRI | – | –adults with clinically diagnosed major depressive disorder currently taking a physician prescribed selective serotonin reuptake inhibitor as treatment. |
| SNRI | – | –adults with clinically diagnosed major depressive disorder currently taking a physician prescribed serotonin norepinephrine reuptake inhibitor as treatment. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be recruited from Centre County Pennsylvania including on the Penn State University campus.
Key inclusion criteria (11 listed)
- Non-depressed adults aged 18-40 years;
- OR adults aged 18-40 years with clinically diagnosed major depressive disorder according to DSM-V criteria not currently receiving antidepressant treatment;
- OR adults aged 18-40 years with clinically diagnosed major depressive disorder with at least 2 weeks of treatment with a selective serotonin reuptake inhibitor;
- OR aged 18-40 years adults with clinically diagnosed major depressive disorder with at least 2 weeks of treatment with a serotonin norepinephrine reuptake inhibitor;
- All participants will be asymptomatic and no signs/symptoms of disease according to the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription (chest pain or pressure, dizziness, joint pain, and signs of cardiovascular disease);
Key exclusion criteria (16 listed)
- BMI > 35
- Are pregnant or planning to become pregnant in the next 12 months;
- Concurrently participate in another study involving physical activity or weight loss;
- Plan to have surgery or relocate outside the area within the next year;
- Medications that could alter cardiovascular or thermoregulatory responses to exercise (beta blockers, antipyretics, tricyclic antidepressants, diuretics, etc.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skin blood flow
Time frame: Monitored continuously during the passive heating experimental trial, about 2 hours.
Skin blood flow response to whole body heating is continuously monitored during the experimental trial, about 2 hours.
Local Sweat Rate
Time frame: Monitored continuously during the passive heating experimental trial, about 2 hours.
A small sweat capsule is placed on the forearm for the duration of the passive whole body heating experiment, about 2 hours.
Core Temperature
Time frame: Monitored continuously during the passive heating experimental trial, about 2 hours.
Changes in body temperature are measured through a telemetry pill swallowed before each experiment.
1 secondary outcome
Body Mass
Time frame: Will be measured once immediately before and once immediately after the passive heating experimental trail.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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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.
W. Larry Kenney principal investigator
The Pennsylvania State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Selective Serotonin Reuptake Inhibitor, run by Penn State University 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 11 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 3 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact W. Larry Kenney (814-863-1672, w7k@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin blood flow (time frame: Monitored continuously during the passive heating experimental trial, about 2 hours.). The study lists 3 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 3 Feb 2026.