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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

Must not have

Using medication that might impact thermoregulatory capacity within 3 days of receiving WBH treatment, including: diuretics, barbiturates, beta-blockers, antipsychotic agents, anti-cholinergic agents or chronic use of antihistamines, aspirin (other than low-dose for prophylactic purposes), non-steroidal anti-inflammatory drugs (NSAIDs), systemic corticosteroids, or cytokine antagonists

Has a history of or an increased risk for gastrointestinal perforation such as a history of diverticulitis, stomach or intestinal ulcers or abdominal pain that does not go away

Timeline

Screening 3 weeks

Treatment Varies

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

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any medication that affects my body's temperature regulation.

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I have a history of serious stomach or intestinal issues.

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I do not have any serious unstable health conditions.

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I have a fever over 99°F with no known cause.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 / 6Eligibility criteria met