NCT03906149

Whole-body Hyperthermia for Moderate to Severe Depressive Disorder

Whole-body Hyperthermia for Moderate to Severe Depressive Disorder - a Randomized Controlled Tiral

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Universität Duisburg-Essen · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-07-01
• Primary completion: 2023-01-20
• Completion: 2023-01-20
• First posted: 2019-04-08
• Last updated: 2023-11-22

Locations

1 site across 1 country: Germany