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

Plain English Summary

Impact of Depression on Thermoregulation is a Not Applicable clinical trial sponsored by Penn State University studying Depression, Selective Serotonin Reuptake Inhibitor. This study investigates how major depression and its treatments affect the body's ability to regulate temperature during heat exposure. It is for adults aged 18-40 who have been diagnosed with major depression, are taking specific antidepressants (SSRIs or SNRIs), or are not depressed. Participation involves undergoing a heat stress test while researchers monitor skin blood flow, sweating, and body temperature. Alternatives include discussing body temperature regulation with a doctor or seeking information on how depression can affect physical health. The trial aims to enroll 64 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are an adult aged 18-40 and are either not depressed, have major depression and are not on medication, or have major depression and have been taking an SSRI or SNRI for at least two weeks. You cannot join if you have a BMI over 35, are pregnant, plan to become pregnant, are currently in another study involving physical activity or weight loss, or have certain medical conditions like bleeding disorders, kidney/liver issues, or other psychiatric disorders. Participants must be generally healthy with no signs of disease, have controlled blood pressure, and not be taking medications that could interfere with the study's measurements, except for the specified SSRIs or SNRIs. You must also have a healthy level of cardiorespiratory fitness (VO2max) and be proficient in English. This trial is studying Depression, Selective Serotonin Reuptake Inhibitor, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes measure how your skin's blood flow, sweating, and core body temperature change when exposed to heat, helping researchers understand if depression or its treatments affect your bod The specific primary outcome measures are: Skin blood flow (Monitored continuously during the passive heating experimental trial, about 2 hours.); Local Sweat Rate (Monitored continuously during the passive heating experimental trial, about 2 hours.); Core Temperature (Monitored continuously during the passive heating experimental trial, about 2 hours.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is important because it aims to understand how depression and its treatments might alter the body's natural ability to cope with heat, potentially identifying new ways to manage physical we This research targets Depression, Selective Serotonin Reuptake Inhibitor, where improved treatment options are needed.

Investor Insight

This observational study by a university sponsor suggests a focus on understanding a specific physiological aspect of depression, indicating a potential area for future therapeutic development in mana

Is This Trial Right for Me?

Ask your doctor if you have any concerns about how depression or your medications might affect your body's response to heat. Participation involves a heat stress test where researchers will monitor your body's temperature, sweating, and blood flow. You will need to attend appointments at Noll Laboratory in University Park, Pennsylvania. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 64 participants

Primary Outcomes

• Skin blood flow (Monitored continuously during the passive heating experimental trial, about 2 hours.)
• Local Sweat Rate (Monitored continuously during the passive heating experimental trial, about 2 hours.)
• Core Temperature (Monitored continuously during the passive heating experimental trial, about 2 hours.)

Secondary Outcomes

• Body Mass (Will be measured once immediately before and once immediately after the passive heating experimental trail.)

Full Eligibility Criteria

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.

Trial Locations

• Noll Laboratory, University Park, Pennsylvania, United States

Frequently Asked Questions

Related Conditions

• Depression
• Major Depressive Disorder
• Selective Serotonin Reuptake Inhibitor (SSRI)
• Serotonin Norepinephrine Reuptake Inhibitor (SNRI)
• Thermoregulation
• Heat Stress
• Cardiovascular Health
• Mental Health
• Psychiatric Disorders
• Body Temperature Regulation

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