Clinical trial NCT03906149: Whole-body Hyperthermia for Moderate to Severe Depressive Disorder
Official title: Whole-body Hyperthermia for Moderate to Severe Depressive Disorder - a Randomized Controlled Tiral
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Unipolar
Keywords: Depression
Hyperthermia
Randomized Controlled Trial
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Depression Severity: clinician-rated
timeFrame: week 6
Secondary outcomes:
measure: Depression Severity: clinician-rated
timeFrame: week 1
measure: Depression Severity: clinician-rated
timeFrame: week 3
measure: Depression Severity: clinician-rated
timeFrame: week 12
measure: Depression Severity: patient-rated
timeFrame: week 1
measure: Depression Severity: patient-rated
timeFrame: week 3
measure: Depression Severity: patient-rated
timeFrame: week 6
measure: Depression Severity: patient-rated
timeFrame: week 12
measure: Global improvement: clinician-rated
timeFrame: week 1
measure: Global improvement: clinician-rated
timeFrame: week 3
measure: Global improvement: clinician-rated
timeFrame: week 6
measure: Global improvement: clinician-rated
timeFrame: week 12
measure: Global Functioning: clinician-rated
timeFrame: week 1
measure: Global Functioning: clinician-rated
timeFrame: week 3
measure: Global Functioning: clinician-rated
timeFrame: week 6
measure: Global Functioning: clinician-rated
timeFrame: week 12
measure: Fatigue: patient-rated
timeFrame: week 1
measure: Fatigue: patient-rated
timeFrame: week 3
measure: Fatigue: patient-rated
timeFrame: week 6
measure: Fatigue: patient-rated
timeFrame: week 12
measure: Stress: patient-rated
timeFrame: week 1
measure: Stress: patient-rated
timeFrame: week 3
measure: Stress: patient-rated
timeFrame: week 6
measure: Stress: patient-rated
timeFrame: week 12
measure: Quality of Life: patient-rated
timeFrame: week 1
measure: Quality of Life: patient-rated
timeFrame: week 3
measure: Quality of Life: patient-rated
timeFrame: week 6
measure: Quality of Life: patient-rated
timeFrame: week 12
measure: Biomarkers: interleukin 2
timeFrame: week 1
measure: Biomarkers: interleukin 2
timeFrame: week 3
measure: Biomarkers: interleukin 2
timeFrame: week 6
measure: Biomarkers: interleukin 2
timeFrame: week 12
measure: Biomarkers: interleukin 6
timeFrame: week 1
measure: Biomarkers: interleukin 6
timeFrame: week 3
measure: Biomarkers: interleukin 6
timeFrame: week 6
measure: Biomarkers: interleukin 6
timeFrame: week 12
measure: Biomarkers: interleukin 10
timeFrame: week 1
measure: Biomarkers: interleukin 10
timeFrame: week 3
measure: Biomarkers: interleukin 10
timeFrame: week 6
measure: Biomarkers: interleukin 10
timeFrame: week 12
measure: Biomarkers: tumor necrosis factor-alpha
timeFrame: week 1
measure: Biomarkers: tumor necrosis factor-alpha
timeFrame: week 3
measure: Biomarkers: tumor necrosis factor-alpha
timeFrame: week 6
measure: Biomarkers: tumor necrosis factor-alpha
timeFrame: week 12
measure: Biomarkers: high-sensitivity C-reactive Protein
timeFrame: week 1
measure: Biomarkers: high-sensitivity C-reactive Protein
timeFrame: week 3
measure: Biomarkers: high-sensitivity C-reactive Protein
timeFrame: week 6
measure: Biomarkers: high-sensitivity C-reactive Protein
timeFrame: week 12
measure: Biomarkers: soluble intercellular adhesion molecule-1
timeFrame: week 1
measure: Biomarkers: soluble intercellular adhesion molecule-1
timeFrame: week 3
measure: Biomarkers: soluble intercellular adhesion molecule-1
timeFrame: week 6
measure: Biomarkers: soluble intercellular adhesion molecule-1
timeFrame: week 12
measure: Biomarkers: tryptophan
timeFrame: week 1
measure: Biomarkers: tryptophan
timeFrame: week 3
measure: Biomarkers: tryptophan
timeFrame: week 6
measure: Biomarkers: tryptophan
timeFrame: week 12
measure: Biomarkers: kynurenine
timeFrame: week 1
measure: Biomarkers: kynurenine
timeFrame: week 3
measure: Biomarkers: kynurenine
timeFrame: week 6
measure: Biomarkers: kynurenine
timeFrame: week 12
measure: Biomarkers: neopterin
timeFrame: week 1
measure: Biomarkers: neopterin
timeFrame: week 3
measure: Biomarkers: neopterin
timeFrame: week 6
measure: Biomarkers: neopterin
timeFrame: week 12
measure: Adverse Events
timeFrame: week 1
measure: Adverse Events
timeFrame: week 3
measure: Adverse Events
timeFrame: week 6
measure: Adverse Events
timeFrame: week 12
Other outcomes:
measure: Treatment Expectations
timeFrame: week -1
Locations:
city: Essen
country: Germany
facility: Department of Psychiatry, Psychotherapy and Addiciton Medicine, Evang. Kliniken Essen-Mitte
Study officials:
affiliation: Center for Integrative Medicine and Health, University Hospital Essen, University of Duisburg-Essen
name: Gustav Dobos, Prof. MD
role: STUDY_DIRECTOR
References: