Recruiting

SSRIs & SNRIs

Sponsor:

Penn State University

Code:

NCT06805851

Conditions

Depression

Selective Serotonin Reuptake Inhibitor

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT06805851

Start date

Mar 1, 2025

Status verified date

Jan, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Dec 1, 2025

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

64 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Skin blood flow [ Time Frame: Monitored continuously during the passive heating experimental trial, about 2 hours. ]
  • Local Sweat Rate [ Time Frame: Monitored continuously during the passive heating experimental trial, about 2 hours. ]
  • Core Temperature [ Time Frame: Monitored continuously during the passive heating experimental trial, about 2 hours. ]

Central Contacts and Locations

Central contacts

W. Larry Kenney

814-863-1672w7k@psu.edu

Kat G Fisher

3072037657kgf5118@psu.edu

Locations

Noll Laboratory

Recruiting

University Park, Pennsylvania, United States, 16802

Contacts

Kat Fisher

3072037657kgf5118@psu.edu

More Information

Sponsor

Penn State University

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Penn State University on 2026-02-03.