Multicenter, 3-arm, randomized, controlled study on the rapid antidepressant efficacy and safety of hyperthermic baths in depressio

Not Applicable

• Conditions: F32; F33; Depressive episode; Recurrent depressive disorder

• Registration Number: DRKS00033017
• Lead Sponsor: niklinik Freiburg, Uni-Zenrum Naturheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

Signed Informed Consent Form (ICF)
- patients receiving treatment as usual or who are off antidepressant therapy for at least 4 weeks prior to baseline
- ICD-10 (F32/F33) criteria for single or recurrent nonpsychotic depression >2 weeks (IDCL module for depressive episode)
- MADRS score indicating at least a moderate depression (MARDS = 20)

Exclusion Criteria

- Acute risk of suicide
- Change of antidepressant therapy <4 weeks earlier or intention to change antidepressant therapy within the next two weeks
- Other mental disorder (i.e. borderline personality disorder, bipolar affective disorder, drug and/or alcohol abuse, schizophrenia, anxiety disorder, psychotic depression)
- Contraindication for hot baths (i.e. open wounds, heat urticaria, varicosis, multiple sclerosis, epilepsy, orthostatic dysregulation, pregnancy)
- Severe organic disease (i.e. heart failure)
- Ongoing pension claim

Study & Design

• Study Type: interventional
• Study Design: Not specified