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WBH for Depression

N/A

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females and Males ages 18-65

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention

Awards & highlights

Study Summary

This trialwill study how heating the body can help ease depression symptoms.

Who is the study for?

Adults aged 18-65 with major depressive disorder for at least 4 weeks, able to understand English and consent. They must score ≥24 on a depression scale and use birth control if applicable. Excluded are those pregnant, breastfeeding, recently hospitalized for psychiatric reasons, suicidal, drug users, feverish individuals or those with certain medical conditions or medications that affect body temperature regulation.Check my eligibility

What is being tested?

The study is testing the effects of whole-body hyperthermia (WBH) on immune response and heat shock proteins in depressed patients. It aims to see if heating up the body can reduce symptoms of depression compared to a sham treatment without actual warming.See study design

What are the potential side effects?

Potential side effects may include discomfort due to heat exposure such as sweating or overheating during WBH treatment. There might also be risks associated with sedatives used during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

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I have been diagnosed with major depression for at least 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-intervention), one week post-intervention, two weeks post-intervention, four weeks post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in serum levels of Interleukin-6 from baseline to post-treatment

Decreases in depressive severity, as measured by the Inventory of Depressive Symptomatology, Clinician-Rated (IDS-CR)

Decreases in depressive severity, as measured by the Symptoms of Depression Questionnaire (SDQ)

Secondary outcome measures

Changes in mental and physical functioning, as measured by the Patient Rated Outcome Measure Information System, 29-Item (PROMIS-29)

Changes in mood, as measured by the Positive and Negative Affect Schedule (PANAS)

Changes to quality of life, as measured by the Quality of Life, Enjoyment, and Satisfaction Questionnaire

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Whole Body Hyperthermia (WBH)Experimental Treatment1 Intervention

A single treatment of Whole Body Hyperthermia will be administered using the Heckel Hyperthermia device. During this procedure, participants' core body temperature will be elevated to 38.5 degrees Celsius.

Group II: ShamPlacebo Group1 Intervention

Under the sham condition, participants will enter the Heckel Hyperthermia device as in the active treatment condition, but will not receive the whole body hyperthermia treatment, and will instead only receive mild heating.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,941 Previous Clinical Trials

13,200,608 Total Patients Enrolled

National Institute of General Medical Sciences (NIGMS)NIH

271 Previous Clinical Trials

246,961 Total Patients Enrolled

Media Library

WBH (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05366270 — N/A

Heat Stroke Research Study Groups: Sham, Whole Body Hyperthermia (WBH)

Heat Stroke Clinical Trial 2023: WBH Highlights & Side Effects. Trial Name: NCT05366270 — N/A

WBH (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05366270 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation enrolling participants who are older than 20 years?

"This study has a set age range for participants: 18 to 65. Clinical trials catering to those younger than this age limit total 248, while 1294 studies are available for the aged over 65 years old."

Answered by AI

Are there any remaining vacancies to partake in this experiment?

"Affirmative. The information hosted on clinicaltrials.gov implies that this medical trial is recruiting patients, having first been posted and last updated in November 1st 2022. Currently the study requires 60 volunteers from a single site to take part."

Answered by AI

What is the current capacity for enrolment in this research endeavor?

"Affirmative. The clinicaltrials.gov website asserts that the trial, which was initiated on November 1st 2022, is actively accepting applicants. At present, 60 patients need to be enrolled at one medical centre."

Answered by AI

Is it possible for me to be part of this research endeavor?

"Eligibility for this study necessitates that patients have hyperthermia and are of legal age (18-65). There is space for roughly 60 individuals to join the research."

Answered by AI

What goals is this research endeavor aiming to achieve?

"This clinical trial's main objective is to evaluate the reduction in depressive severity, monitored at baseline (pre-intervention), 1 hour post-intervention, 24 hours post-intervention, and one week post-intervention. This metric will be measured using the Symptoms of Depression Questionnaire (SDQ). Secondary objectives include observing reductions in ruminative thinking with Ruminative Responses Scale (RRS) scores ranging from 22 to 88 - lower indicating fewer rumination episodes; changes in mental and physical functioning via Patient Rated Outcome Measure Information System 29 Item (PROMIS-29) 4 to 20 scale where lower values denote"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Peripheral Neuroimmune Mechanisms of Hyperthermia

Simmie L. Foster, MD 2022. "Peripheral Neuroimmune Mechanisms of Hyperthermia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05366270.

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