Whole-body Hyperthermia for Mild to Moderate Depressive Disorder

NCT03906175 | Completed

• 1 other identifier: 18-8439-BO
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to investigate the effectiveness of whole-body hyperthermia in comparison to wait list on depressive symptom severity in patients with mild to moderate depressive disorder currently not under psychotherapeutic or antidepressant drug treatment. Secondary aims included further quality of life outcomes, immunological parameters, and tolerability/safety of the hyperthermia.

Conditions

Depression, Unipolar

Keywords

Depression; Hyperthermia; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Depression Severity: clinician-rated

  Hamilton Rating Scale for Depression (HAMD-17)

  week 6

Secondary Outcomes (67)

• Depression Severity: clinician-rated

  week 1

• Depression Severity: clinician-rated

  week 3

• Depression Severity: clinician-rated

  week 12

• Depression Severity: patient-rated

  week 1

• Depression Severity: patient-rated

  week 3

Other Outcomes (1)

• Treatment Expectations

  week -1

Study Arms (2)

Whole-body hyperthermia

EXPERIMENTAL

Whole-body hyperthermia will be applied 2 times during 4 weeks. At week 6, the primary outcome will be assessed. The participants will be reassessed 12 weeks after the start of the treatment with whole-body hyperthermia.

Device: Whole-body hyperthermia

Wait list

NO INTERVENTION

Participants will wait for 6 weeks (primary outcome assessment point). They will then receive the same treatment procedure as the experimental group. They will also be reassessed 12 weeks after the start of the treatment with whole-body hyperthermia.

Interventions

Whole-body hyperthermia DEVICE

Whole-body hyperthermia will be applied two times during 4 weeks (week 0 and 2 after randomization). The hyperthermia will be applied using Heckel-HT3000 MPIIb.

Whole-body hyperthermia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unipolar depression (diagnosed according to the DSM-IV)
• Mild depression: 8-16 points on the HAMD-17 or moderate depression: 17-23 points on the HAMD-17

You may not qualify if:

• Current psychotherapy
• Participants who did not respond to prior antidepressant drug treatment, electroconvulsive therapy, or sleep deprivation (therapy-resistant depression)
• Acute suicidality
• Prior treatment with whole-body hyperthermia
• Contraindications to hyperthermia treatment: acute or feverish infections, severe cardiovascular diseases (e.g. angina pectoris, heart failure, thrombosis, bleeding diathesis), severe gastrointestinal diseases (e.g. renal insufficiency, hepatitis, liver cirrhosis, peptic ulcer), severe neurological diseases (e.g. epilepsy, multiple sclerosis, cerebrovascular malformations or brain tumors), severe endocrine diseases (e.g. hyperthyroidism), or oncological diseases without remission
• Participants taking anti-inflammatory or immunosuppressive drugs
• Participants with severe psychiatric comorbidities (e.g. schizophrenia, schizoaffective disorder, bipolar disorder, dementia, ADHD, obsessive-compulsive disorder, PTSD, alcohol or drug addiction)
• Women during pregnancy and breastfeeding
• Lack of ability to consent

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

Department of Psychiatry, Psychotherapy and Addiciton Medicine, Evang. Kliniken Essen-Mitte

Essen, 45276, Germany

Location

MeSH Terms

Conditions

Depressive Disorder; Depression; Hyperthermia

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Gustav Dobos, Prof. MD

  Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 8, 2019
• Study Start: June 11, 2019
• Primary Completion: August 31, 2023
• Study Completion: September 1, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)