Impact of Depression on Thermoregulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Depression, Selective Serotonin Reuptake Inhibitor. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Thermoregulatory Responses to Heat Stress in Adults With Major Depressive Disorder With and Without Antidepressant Treatment
Overview
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.
Primary outcome measures
- 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.]
Secondary outcome measures (1)
- Body Mass [Time frame: Will be measured once immediately before and once immediately after the passive heating experimental trail.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Noll Laboratory — University Park
Identifiers
NCT: NCT06805851 · Study26326