Whole-body Hyperthermia for Moderate to Severe Depressive Disorder

Depression, Unipolar Clinical Trial

— HYPE2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03906149
• Other study ID #: 18-8440-BO
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: January 20, 2023

Study information

• Verified date: November 2023
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Depression
• Depression, Unipolar
• Depressive Disorder
• Fever
• Hyperthermia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Department of Psychiatry, Psychotherapy and Addiciton Medicine, Evang. Kliniken Essen-Mitte	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Expectations	Treatment Credibility Scale (TCS)	week -1
Primary	Depression Severity: clinician-rated	Hamilton Rating Scale for Depression (HAMD-17)	week 6
Secondary	Depression Severity: clinician-rated	Hamilton Rating Scale for Depression (HAMD-17)	week 1
Secondary	Depression Severity: clinician-rated	Hamilton Rating Scale for Depression (HAMD-17)	week 3
Secondary	Depression Severity: clinician-rated	Hamilton Rating Scale for Depression (HAMD-17)	week 12
Secondary	Depression Severity: patient-rated	Beck Depression Inventory II (BDI-II)	week 1
Secondary	Depression Severity: patient-rated	Beck Depression Inventory II (BDI-II)	week 3
Secondary	Depression Severity: patient-rated	Beck Depression Inventory II (BDI-II)	week 6
Secondary	Depression Severity: patient-rated	Beck Depression Inventory II (BDI-II)	week 12
Secondary	Global improvement: clinician-rated	Clinical Global Impression Scale (CGI)	week 1
Secondary	Global improvement: clinician-rated	Clinical Global Impression Scale (CGI)	week 3
Secondary	Global improvement: clinician-rated	Clinical Global Impression Scale (CGI)	week 6
Secondary	Global improvement: clinician-rated	Clinical Global Impression Scale (CGI)	week 12
Secondary	Global Functioning: clinician-rated	Global Assessment of Functioning Scale (GAF)	week 1
Secondary	Global Functioning: clinician-rated	Global Assessment of Functioning Scale (GAF)	week 3
Secondary	Global Functioning: clinician-rated	Global Assessment of Functioning Scale (GAF)	week 6
Secondary	Global Functioning: clinician-rated	Global Assessment of Functioning Scale (GAF)	week 12
Secondary	Fatigue: patient-rated	Multidimensional Fatigue Inventory (MFI)	week 1
Secondary	Fatigue: patient-rated	Multidimensional Fatigue Inventory (MFI)	week 3
Secondary	Fatigue: patient-rated	Multidimensional Fatigue Inventory (MFI)	week 6
Secondary	Fatigue: patient-rated	Multidimensional Fatigue Inventory (MFI)	week 12
Secondary	Stress: patient-rated	Perceived Stress-Scale (PSS)	week 1
Secondary	Stress: patient-rated	Perceived Stress-Scale (PSS)	week 3
Secondary	Stress: patient-rated	Perceived Stress-Scale (PSS)	week 6
Secondary	Stress: patient-rated	Perceived Stress-Scale (PSS)	week 12
Secondary	Quality of Life: patient-rated	Short Form Health Survey (SF-12)	week 1
Secondary	Quality of Life: patient-rated	Short Form Health Survey (SF-12)	week 3
Secondary	Quality of Life: patient-rated	Short Form Health Survey (SF-12)	week 6
Secondary	Quality of Life: patient-rated	Short Form Health Survey (SF-12)	week 12
Secondary	Biomarkers: interleukin 2	IL-2	week 1
Secondary	Biomarkers: interleukin 2	IL-2	week 3
Secondary	Biomarkers: interleukin 2	IL-2	week 6
Secondary	Biomarkers: interleukin 2	IL-2	week 12
Secondary	Biomarkers: interleukin 6	IL-6	week 1
Secondary	Biomarkers: interleukin 6	IL-6	week 3
Secondary	Biomarkers: interleukin 6	IL-6	week 6
Secondary	Biomarkers: interleukin 6	IL-6	week 12
Secondary	Biomarkers: interleukin 10	IL-10	week 1
Secondary	Biomarkers: interleukin 10	IL-10	week 3
Secondary	Biomarkers: interleukin 10	IL-10	week 6
Secondary	Biomarkers: interleukin 10	IL-10	week 12
Secondary	Biomarkers: tumor necrosis factor-alpha	TNF-alpha	week 1
Secondary	Biomarkers: tumor necrosis factor-alpha	TNF-alpha	week 3
Secondary	Biomarkers: tumor necrosis factor-alpha	TNF-alpha	week 6
Secondary	Biomarkers: tumor necrosis factor-alpha	TNF-alpha	week 12
Secondary	Biomarkers: high-sensitivity C-reactive Protein	hs-CRP	week 1
Secondary	Biomarkers: high-sensitivity C-reactive Protein	hs-CRP	week 3
Secondary	Biomarkers: high-sensitivity C-reactive Protein	hs-CRP	week 6
Secondary	Biomarkers: high-sensitivity C-reactive Protein	hs-CRP	week 12
Secondary	Biomarkers: soluble intercellular adhesion molecule-1	sICAM-1	week 1
Secondary	Biomarkers: soluble intercellular adhesion molecule-1	sICAM-1	week 3
Secondary	Biomarkers: soluble intercellular adhesion molecule-1	sICAM-1	week 6
Secondary	Biomarkers: soluble intercellular adhesion molecule-1	sICAM-1	week 12
Secondary	Biomarkers: tryptophan	tryptophan	week 1
Secondary	Biomarkers: tryptophan	tryptophan	week 3
Secondary	Biomarkers: tryptophan	tryptophan	week 6
Secondary	Biomarkers: tryptophan	tryptophan	week 12
Secondary	Biomarkers: kynurenine	kynurenine	week 1
Secondary	Biomarkers: kynurenine	kynurenine	week 3
Secondary	Biomarkers: kynurenine	kynurenine	week 6
Secondary	Biomarkers: kynurenine	kynurenine	week 12
Secondary	Biomarkers: neopterin	neopterin	week 1
Secondary	Biomarkers: neopterin	neopterin	week 3
Secondary	Biomarkers: neopterin	neopterin	week 6
Secondary	Biomarkers: neopterin	neopterin	week 12
Secondary	Adverse Events	Number of patients with adverse events, total number and type of adverse events	week 1
Secondary	Adverse Events	Number of patients with adverse events, total number and type of adverse events	week 3
Secondary	Adverse Events	Number of patients with adverse events, total number and type of adverse events	week 6
Secondary	Adverse Events	Number of patients with adverse events, total number and type of adverse events	week 12