Whole-body Hyperthermia for Mild to Moderate Depressive Disorder

  • STATUS
    Recruiting
  • End date
    Jun 24, 2023
  • participants needed
    46
  • sponsor
    Universität Duisburg-Essen
Updated on 24 November 2021
depression
antidepressants
depressive symptoms
psychotropic drugs

Summary

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.

Details
Condition Endogenous depression, major depressive disorder
Treatment Whole-body hyperthermia
Clinical Study IdentifierNCT03906175
SponsorUniversität Duisburg-Essen
Last Modified on24 November 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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