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NCT Number: NCT06805851

Impact of Depression on Thermoregulation

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.

Recruiting

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Noll Laboratory

University Park, Pennsylvania, 16802, United States

Location status: Recruiting

Location contact

Kat Fisher

CONTACT

[email protected]

3072037657

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Body Mass

    Time frame: Will 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kat G Fisher

CONTACT

[email protected]

3072037657

W. Larry Kenney

CONTACT

[email protected]

814-863-1672

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Feb 3, 2025
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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