Impact of Depression on Thermoregulation

NCT06805851 | Recruiting DMC

• 1 other identifier: Study26326
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Selective Serotonin Reuptake Inhibitor

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Skin blood flow

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

  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.

  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.

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

Secondary Outcomes (1)

• Body Mass

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

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Noll Laboratory

University Park, Pennsylvania, 16802, United States

RECRUITING

MeSH Terms

Conditions

Depression; Heat Stress Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Wounds and Injuries

Study Officials

• W. Larry Kenney

  The Pennsylvania State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

W. Larry Kenney

CONTACT

814-863-1672; w7k@psu.edu

Kat G Fisher

CONTACT

3072037657; kgf5118@psu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 3, 2025
• Study Start: March 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): January 30, 2027
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)