Whole-body Hyperthermia for Moderate to Severe Depressive Disorder (HYPE2)

Universität Duisburg-Essen

Status: Completed

Conditions: Depression, Unipolar

Treatments: Combination Product: Whole-body hyperthermia + standard medical care; Combination Product: Standard medical care

Study type: Interventional

Funder types: Other

Identifiers

NCT03906149

18-8440-BO

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Whole-body hyperthermia + standard medical care

Experimental group

Description:

Whole-body hyperthermia will be applied 2 times during 4 weeks in addition to guideline-based standard medical care for depression (anti-depressive drug treatment in combination with psychotherapy). At week 6, the primary outcome will be assessed. The participants will be reassessed 12 weeks after the start of the treatment with whole-body hyperthermia.

Treatment:

Combination Product: Whole-body hyperthermia + standard medical care

Standard medical care

Active Comparator group

Description:

Participants will maintain standard medical care for depression (anti-depressive drug treatment in combination with psychotherapy). At week 6, the primary outcome will be assessed. The participants will be reassessed 12 weeks after randomization.

Treatment:

Combination Product: Standard medical care