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Impact of Depression on Thermoregulation

Thermoregulatory Responses to Heat Stress in Adults With Major Depressive Disorder With and Without Antidepressant Treatment

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06805851
Enrollment
64
Registered
2025-02-03
Start date
2025-03-01
Completion date
2027-01-30
Last updated
2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Selective Serotonin Reuptake Inhibitor

Keywords

thermoregulation, heat stress, depression, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors

Brief 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.

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.

Interventions

None listed

Sponsors

Penn State University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Skin blood flowMonitored 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 RateMonitored 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 TemperatureMonitored continuously during the passive heating experimental trial, about 2 hours.Changes in body temperature are measured through a telemetry pill swallowed before each experiment.

Secondary

MeasureTime frameDescription
Body MassWill be measured once immediately before and once immediately after the passive heating experimental trail.Body mass is measured on a scale before and after the passive heating experimental trail.

Countries

United States

Contacts

CONTACTW. Larry Kenney
w7k@psu.edu814-863-1672
CONTACTKat G Fisher
kgf5118@psu.edu3072037657
PRINCIPAL_INVESTIGATORW. Larry Kenney

The Pennsylvania State University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026