Whole-body Hyperthermia for Moderate to Severe Depressive Disorder

NACompletedINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

July 1, 2019

Primary Completion Date

January 20, 2023

Study Completion Date

January 20, 2023

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.

Trial Locations (1)

45276

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

All Listed Sponsors
lead

Universität Duisburg-Essen

OTHER

NCT03906149 - Whole-body Hyperthermia for Moderate to Severe Depressive Disorder | Biotech Hunter | Biotech Hunter