Whole-body Hyperthermia for Moderate to Severe Depressive Disorder

NCT03906149 | Completed

• 1 other identifier: 18-8440-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 addition to standard medical care in comparison to standard medical care alone on depressive symptom severity in patients with moderate to severe depressive disorder. 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 + standard medical care

EXPERIMENTAL

Whole-body hyperthermia will be applied 2 times during 4 weeks in addition to guideline-based standard medical care for depression (anti-depressive drug treatment in combination with psychotherapy). 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.

Combination Product: Whole-body hyperthermia + standard medical care

Standard medical care

ACTIVE COMPARATOR

Participants will maintain standard medical care for depression (anti-depressive drug treatment in combination with psychotherapy). At week 6, the primary outcome will be assessed. The participants will be reassessed 12 weeks after randomization.

Combination Product: Standard medical care

Interventions

Whole-body hyperthermia + standard medical care COMBINATION_PRODUCT

Whole-body hyperthermia will be applied two times during 4 weeks (week 0 and 2 after randomization) in addition to standard medical care. The hyperthermia will be applied using Heckel-HT3000 MPIIb. During the 6 weeks of primary observation, the current medication should be maintained. The dose may be optimized with respect to clinical effectiveness and the reduction of side effects. The type of medication should not be changed during the 6 weeks. The use of additional somatic therapies such as sleep deprivation, light therapy, electroconvulsive therapy, or transcranial magnetic stimulation is not allowed.

Whole-body hyperthermia + standard medical care

Standard medical care COMBINATION_PRODUCT

Standard medical care included guideline-based anti-depressive drug treatment in combination with psychotherapy. During the 6 weeks of primary observation, the current medication should be maintained. The dose may be optimized with respect to clinical effectiveness and the reduction of side effects. The type of medication should not be changed during the 6 weeks. The use of additional somatic therapies such as sleep deprivation, light therapy, electroconvulsive therapy, or transcranial magnetic stimulation is not allowed.

Standard medical care

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)
• Moderate depression: 17-23 points on the HAMD-17 or severe depression: ≥24 points on the HAMD-17

You may not qualify if:

• 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: July 1, 2019
• Primary Completion: January 20, 2023
• Study Completion: January 20, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)