Whole-body Hyperthermia for Moderate to Severe Depressive Disorder

Universität Duisburg-Essen46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Depression, Unipolar

Interventions

Whole-body hyperthermia + standard medical careCOMBINATION_PRODUCT

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 careCOMBINATION_PRODUCT

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Essen, Germany

Outcomes

Primary Outcomes

Depression Severity: clinician-rated

Hamilton Rating Scale for Depression (HAMD-17)

Time frame: week 6

Secondary Outcomes

Depression Severity: clinician-rated

Hamilton Rating Scale for Depression (HAMD-17)

Time frame: week 1

Depression Severity: clinician-rated

Hamilton Rating Scale for Depression (HAMD-17)

Time frame: week 3

Depression Severity: clinician-rated

Hamilton Rating Scale for Depression (HAMD-17)

Time frame: week 12

Depression Severity: patient-rated

Beck Depression Inventory II (BDI-II)

Time frame: week 1

Depression Severity: patient-rated

Beck Depression Inventory II (BDI-II)

Time frame: week 3

Depression Severity: patient-rated

Beck Depression Inventory II (BDI-II)

Time frame: week 6

Depression Severity: patient-rated

Beck Depression Inventory II (BDI-II)

Time frame: week 12

Global improvement: clinician-rated

Clinical Global Impression Scale (CGI)

Time frame: week 1

Data from ClinicalTrials.gov

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