Whole-body Hyperthermia for Mild to Moderate Depressive Disorder (HYPE1)

Universität Duisburg-Essen

Status: Completed

Conditions: Depression, Unipolar

Treatments: Device: Whole-body hyperthermia

Study type: Interventional

Funder types: Other

Identifiers

NCT03906175

18-8439-BO

Details and patient eligibility

About

The primary aim of this study is to investigate the effectiveness of whole-body hyperthermia in comparison to wait list on depressive symptom severity in patients with mild to moderate depressive disorder currently not under psychotherapeutic or antidepressant drug treatment.

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)
• Mild depression: 8-16 points on the HAMD-17 or moderate depression: 17-23 points on the HAMD-17

Exclusion criteria

• Current psychotherapy
• Antidepressant drug treatment in the last 4 weeks before study inclusion
• 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

Experimental group

Description:

Whole-body hyperthermia will be applied 2 times during 4 weeks. 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:

Device: Whole-body hyperthermia

Wait list

No Intervention group

Description:

Participants will wait for 6 weeks (primary outcome assessment point). They will then receive the same treatment procedure as the experimental group. They will also be reassessed 12 weeks after the start of the treatment with whole-body hyperthermia.