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Whole-body Hyperthermia for Moderate to Severe Depressive Disorder

NCT03906149 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-11-22

No results posted yet for this study

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

Interventions

COMBINATION_PRODUCT

Whole-body hyperthermia + standard medical care

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.

COMBINATION_PRODUCT

Standard medical care

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.

Sponsors & Collaborators

  • Universität Duisburg-Essen

    lead OTHER

Principal Investigators

  • Gustav Dobos, Prof. MD · Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2023-01-20
Completion
2023-01-20

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03906149 on ClinicalTrials.gov