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RecruitingNCT06805851Updated Feb 3, 2026

Impact of Depression on Thermoregulation

An observational study in Depression and Selective Serotonin Reuptake Inhibitor, sponsored by Penn State University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Penn State University · Observational

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
64
Ages
18 Years to 40 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Depression
  • Selective Serotonin Reuptake Inhibitor

Keywords

  • thermoregulation
  • heat stress
  • depression
  • selective serotonin reuptake inhibitors
  • serotonin norepinephrine reuptake inhibitors
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 64 is below the median of 160 across 1,084 observational studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Participants will be recruited from Centre County Pennsylvania including on the Penn State University campus.

Inclusion criteria

  • 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;
  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
64 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Skin blood flow

    Skin blood flow response to whole body heating is continuously monitored during the experimental trial, about 2 hours.

    Time frame: Monitored continuously during the passive heating experimental trial, about 2 hours.

  2. 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.

    Time frame: Monitored continuously during the passive heating experimental trial, about 2 hours.

  3. Core Temperature

    Changes in body temperature are measured through a telemetry pill swallowed before each experiment.

    Time frame: 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.

    Time frame: Will be measured once immediately before and once immediately after the passive heating experimental trail.

07

Study locations

1 of 1 sites recruiting
  • Noll Laboratory
    University Park, Pennsylvania 16802, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06805851
Lead sponsor
Penn State University
Responsible party
W. Larry Kenney (Professor, Penn State University) — Principal investigator
First posted
Feb 3, 2025
Start date
Mar 1, 2025
Primary completion
Dec 1, 2025
Completion
Jan 30, 2027 (estimated)
Last update
Feb 3, 2026

Study contacts

W. Larry Kenney
Contact
w7k@psu.edu
814-863-1672
Kat G Fisher
Contact
kgf5118@psu.edu
3072037657
W. Larry Kenney
principal investigator · The Pennsylvania State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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