NCT05366270

Peripheral Neuroimmune Mechanisms of Hyperthermia

Recruiting
NAAges 18–65InterventionalBasic science
Massachusetts General Hospital
~60 participants
Updated 2023-03-10 on ClinicalTrials.gov
What's tested:WBHSham

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in serum levels of Interleukin-6 from baseline to post-treatment
Measured over baseline (pre-intervention), one hour post-intervention, 24 hours post-intervention, one week post-intervention
+2 more outcomes measured
Hyperthermia
Major Depressive Disorder
Inflammation
1 sites across 1 states
Massachusetts1

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  • Changes in serum levels of Interleukin-6 from baseline to post-treatmentbaseline (pre-intervention), one hour post-intervention, 24 hours post-intervention, one week post-intervention

    Changes in serum levels of Interleukin-6 from baseline to post-treatment, measured by immunoassay

  • Decreases in depressive severity, as measured by the Inventory of Depressive Symptomatology, Clinician-Rated (IDS-CR)baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention

    The Inventory of Depressive Symptomatology is a valid and reliable 30-item measure that is designed to assess severity of depression. The questions focus on neurovegetative and other depressive symptoms experienced over the past seven days. Possible values range from 0 to 84, with lower scores indicating lower depressive severity. A decrease of 50% or more in the IDS-CR score is considered to be a positive response to treatment, while a final score of 11 or less is considered typical remission. Depressive severity will be measured at baseline and at three timepoints post-intervention using the IDS-CR.

  • Decreases in depressive severity, as measured by the Symptoms of Depression Questionnaire (SDQ)baseline (pre-intervention), 24 hours post-intervention, one week post-intervention, two weeks post-intervention, four weeks post-intervention

    The Symptoms of Depression Questionnaire (SDQ) assesses irritability, anger attacks, and anxiety symptoms together with the commonly considered symptoms of depression. Depressive severity will be measured at baseline and at four timepoints post-intervention using the SDQ. Possible values range from 44 to 264, with lower scores indicating lower depressive severity.