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RecruitingHyperthermiaMajor Depressive DisorderInflammation

Peripheral Neuroimmune Mechanisms of Hyperthermia

Eligible age

18–65 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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About this study

The goal of this study is to examine how whole-body hyperthermia affects the thermoinflammatory profile, which includes the combined immune and heat shock response, in patients with depression and whether these changes correlate with decreased depression in individuals with Major Depressive Disorder.

Sponsor: Massachusetts General Hospital

You may qualify if…

  • ✓ 1. Females and Males ages 18-65
  • ✓ 2. English language proficiency
  • ✓ 3. Ability to provide informed consent
  • ✓ 4. Have a current primary psychiatric diagnosis of major depressive disorder (MDD) of at least 4 weeks duration, as defined by Diagnostic \& Statistical Manual, 5th Edition (DSM-5) criteria using the MINI.
  • ✓ 5. Score of ≥ 24 on the Inventory of Depressive Symptomatology - Clinician Rated (IDS-CR)
  • ✓ 6. Individuals of childbearing potential must use an acceptable form of birth control.

You may not qualify if…

  • ✕ 1. Pregnancy or planned pregnancy during study
  • ✕ 2. Current breastfeeding
  • ✕ 3. History of psychiatric hospitalization within the past year
  • ✕ 4. Active suicidal intent ("yes" on item 4 or 5 on the Columbia-Suicide Severity Rating Scale)
  • ✕ 5. History of bipolar disorder, psychotic disorders, eating disorders, and/or substance abuse or dependence (within the last year), as per the Mini-International Neuropsychiatric Interview (MINI)
  • ✕ 6. Meeting DSM-5 criteria at screening for current obsessive compulsive disorder
  • ✕ 7. A ≥25% drop in IDS-CR score from screen (V1) to baseline (V1b)
  • ✕ 8. Positive urine toxicology screen due to illicit drug use or other exclusionary medications. (Potential false positives will be addressed on a case-by-case basis at the discretion of the investigator)

Where it's recruiting

Massachusetts

Boston

Source: ClinicalTrials.gov · NCT05366270 · last updated 2023-03-10

Peripheral Neuroimmune Mechanisms of Hyperthermia · TrialPath