Whole Body Hyperthermia and Major Depression (MDD)

NCT01625546 | Completed DMC

• 1 other identifier: 12-0147-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Major depressive disorder (MDD) is predicted to be the second leading cause of disability worldwide by the year 2020. The economic burden of depression in the United States is significant: $83.1 billion in 2000 and increasing. Much of this burden comes from the high rate of sub-optimal treatment outcomes associated with the disorder. Indeed, only 50% of MDD patients recover in less than 12 weeks with adequate treatment, and up to 20% of patients will fail to adequately respond to all currently available interventions. Moreover, current treatments come at the cost of significant central nervous system (CNS) side effects, further highlighting the need for more effective treatments with fewer side effects. This study will compare temperature ranges from the investigators preliminary studies involving thermoafferent pathways resulting in antidepressant actions with lower temperature ranges not expected to activate these pathways as a control condition, with the goal to evaluate whether previous observations were related to the temperature range in question or can be achieved with other levels.

Conditions

Depressive Disorder, Major

Keywords

Major Depressive Disorder; Whole Body Hyperthermia

Outcome Measures

Primary Outcomes (1)

• 17-item Hamilton Rating Scale for Depression (HAM-D; derived from the 31-item instrument)

  To determine acute and sustained effects of Whole Body Hyperthermia (WBH) on depression severity.

  Screening, at intervention, and at weeks 1, 2, 4 and 6 following the intervention. Additionally, at the open treatment, 1 week following the open treatment and at the 3-month follow up.

Secondary Outcomes (8)

• Change in QIDS (Quick Inventory of Depressive Symptoms) Score from baseline response

  Screening, at intervention, and at weeks 1, 2, 4 and 6 following the intervention. Additionally, at the open treatment, 1 week following the open treatment and at the 3-month follow up.

• Core body temperature monitoring

  3 days (over the weekend) at baseline, week 1 and week 4.

• Skin conductance level

  On the day of the WBH or control treatment, and at one and 4 weeks following the control/intervention.

• Heart Rate Variability

  On the day of the WBH or control treatment, and at one and 4 weeks following the control/intervention.

• EAR Assessment

  3 days (over the weekend) at baseline, week 1 and week 4.

Study Arms (2)

High intensity whole-body infrared heating

EXPERIMENTAL

Subjects will be induced to levels of heat that increases core body temperature to approximately 37.5-38.5 °C using the Whole Body Hyperthermia system.

Device: Whole Body Hyperthermia system

Low intensity whole-body infrared heating

SHAM COMPARATOR

Subjects will be induced to levels of heat that causes only a minor increase in body temperature using Whole Body Hyperthermia system.

Device: Whole Body Hyperthermia system

Interventions

Whole Body Hyperthermia system DEVICE

The Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation. The rise in the body's core temperature is correspondingly rapid and well-tolerated. There are two phases of the thermal challenge, 1) Irradiation phase during which the patient lies recumbent with his/her head positioned outside the tent. The wIRA irradiators are arranged above the exposed upper part of the body; and 2) Heat retention phase during which the patient lies in the chamber with the walls of the tent positioned to retain heat.

High intensity whole-body infrared heating; Low intensity whole-body infrared heating

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female outpatients aged 18-65.
• Able to understand the nature of the study and able to provide written informed consent prior to conduct of any study procedures.
• In the investigator's opinion, has met DSM-IV-TR criteria for Major Depressive Disorder for at least 4 weeks prior to signing consent, single or recurrent episode, without psychotic features, as the subject's primary psychiatric disorder.
• Able to communicate in English with study personnel.
• Has a Hamilton Depression Rating Scale (HDRS) score ≥18 at screening and ≥14 on intervention day.
• For women of child-bearing potential (i.e., one who is biologically capable of becoming pregnant), must be willing to use a medically acceptable form of birth control or practice abstinence for the duration of her participation in the trial.

You may not qualify if:

• Symptoms of depression which, in the investigator's opinion, are better accounted for by a diagnosis other than Major Depressive Disorder.
• Any of the following diagnoses, as identified by the psychiatric evaluation or study assessments:
• A current DSM-IV-TR Axis I diagnosis of Dementia; or
• Any current DSM-IV-TR Axis II diagnosis (i.e. personality disorder) that would suggest potential noncompliance with the protocol; or
• A lifetime history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder Type 1; or
• A diagnosis claustrophobia severe enough that it would impair ability to be in the Heckel HT3000 hyperthermia device
• A current (or within 12 months prior to the Screening visit) diagnosis of Anorexia Nervosa or Bulimia Nervosa
• Subject has met DSM-IV criteria for Substance Abuse in the 3 months prior to screening visit, or non-remitted Substance Dependence in the 6 months prior to screening visit.
• A diagnosis of an anxiety disorder that is considered by the investigator to be of greater source of distress or functional impairment than the patient's depressive symptoms. Subjects with comorbid anxiety disorders not excluded above and considered to be of secondary importance will be permitted in the study.
• Participation in concurrent formal psychotherapy during the trial, or in the 2 weeks prior to the screening visit.
• Individuals with a history of having difficulty swallowing food or large capsules will be excluded from participating in the assessment of core body temperature (because swallowing a large sensor pill is required). The ingestible temperature capsules will not be used in subjects with any known or suspected obstructive disease of the gastrointestinal tract including, but not limited to esophageal stricture, diverticulosis and inflammatory bowel disease (IBD), peptic ulcer disease, Crohn's disease, ulcerative colitis; previous gastrointestinal surgery.
• Subject has a medical condition or disorder that:
• Is unstable and clinically significant, or:
• Could interfere with the accurate assessment of safety or efficacy of treatment, including:
• individuals who are using prescription drugs that may impair thermoregulatory cooling, including diuretics, barbiturates, and beta-blockers, or antihistamines,

Sponsors & Collaborators

• University of Arizona: lead
• Dr. med. h.c. Erwin Braun Foundation: collaborator
• The Depressive and Bipolar Disorder Alternative Treatment Foundation: collaborator
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Related Publications (2)

• Hanusch KU, Janssen CH, Billheimer D, Jenkins I, Spurgeon E, Lowry CA, Raison CL. Whole-body hyperthermia for the treatment of major depression: associations with thermoregulatory cooling. Am J Psychiatry. 2013 Jul;170(7):802-4. doi: 10.1176/appi.ajp.2013.12111395. No abstract available.

  PMID: 23820835 BACKGROUND

• Janssen CW, Lowry CA, Mehl MR, Allen JJ, Kelly KL, Gartner DE, Medrano A, Begay TK, Rentscher K, White JJ, Fridman A, Roberts LJ, Robbins ML, Hanusch KU, Cole SP, Raison CL. Whole-Body Hyperthermia for the Treatment of Major Depressive Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 Aug 1;73(8):789-95. doi: 10.1001/jamapsychiatry.2016.1031.

  PMID: 27172277 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Charles L. Raison, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Professor of Psychiatry

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 21, 2012
• Study Start: July 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 10, 2015

Record last verified: 2015-08

Locations

US (1)