Trial document





This trial has been registered retrospectively.
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  DRKS00015754

Trial Description

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Title

A randomized, double-blind controlled study of the efficacy of infrared-whole body hyperthermia in patients with major depression

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The study aims at investigating the efficacy of whole-body hyperthermia (using infrared-A radiation) in patients suffering from major depression. Previously, whole-body hyperthermia has been used for patients in rheumatology and oncology, whereas mood-lifting effects were noted.
We therefore intend to measure the severity of depressive symptoms using a variety of scales (i.a. HAMD-17, BDI) in 82 patients at different time points before and up to 12 weeks after hyperthermia involving an increase in body temperature to 38.5°C compared to a sham intervention. Hereby we hypothesize a significant antidepressive effect of whole-body hyperthermia.

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Organizational Data

  •   DRKS00015754
  •   2018/10/29
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  •   yes
  •   Approved
  •   EA1/123/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1219-3028 
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Health Condition or Problem studied

  •   F32.1 -  Moderate depressive episode
  •   F32.2 -  Severe depressive episode without psychotic symptoms
  •   F33.1 -  Recurrent depressive disorder, current episode moderate
  •   F33.2 -  Recurrent depressive disorder, current episode severe without psychotic symptoms
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Interventions/Observational Groups

  •   (Infrared-A-) whole-body hyperthermia with increase in body temperature to 38.5°C
  •   Sham-intervention without increase in body temperature to 38.5°C.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

HAMD-17 (Hamilton depression scale) score 6 weeks after intervention

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Secondary Outcome

- HAMD-17 (Hamilton depression scale) score 1, 3, 9 and 12 week(s) after intervention
- BDI-II (Beck Depression-Inventory) score after one day and 1, 3, 6, 9, 12 week(s)
- PANAS (‚Positive and Negative Affect Schedule‘)-score after 1 day, 1, 3, 6, 9 und 12 weeks(s)
- MDBF score after 1 day, 1, 3, 6, 9, 12 weeks(s)
- CGI (Clinical Global Impression) score after 1, 3, 6, 9, 12 week(s)
- BDNF (Brain-derived neurotrophic factor) blood concentration after 3 weeks
- immune parameters (blood) after 1, 3, 6, 12 week(s)
- cortisol concentration (hair) after 1, 3, 6, 9, 12 week(s)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/08/24
  •   82
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

• Age: 18-65 years
• Diagnosis of major depression according to ICD-10/DSM-IV-TR (M.I.N.I.6.0.0)
• score ≥ 16 on Hamilton Depression Scale (HAMD-17, Hamilton 1960)
• no psychotropic medication or stable antidepressive medication for at least 6 weeks
• no psychotherapy or psychotherapy for at least 6 weeks

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Exclusion Criteria

• Bipolar-I-disorder, schizoaffektive disorder, current substance dependency, dementia, organic mental disorder, schizophrenia, Borderline or anti-social personality disorder
• severe diseases of the cardiovascular, pulmonary, hepatobiliary oder renal system
• neurological diseases such as epilepsy, meningitis, stroke
• (unknown) infections or chronic inflammatory diseases
• pregnancy/lactation
• lack of consent ability

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Addresses

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    • Klinik für Psychiatrie und PsychotherapieCharité Campus Mitte
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Abt. für Naturheilkunde der Charité
    • Mr.  Prof. Dr. med.  Andreas  Michalsen 
    • Berlin
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie
    • Ms.  Dr. med.  Astrid  Knobel 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Klinik für Psychiatrie und PsychotherapieCharité Campus Mitte
    • Ms.  Dr. med.  Astrid  Knobel 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Dr. med. h.c. Erwin-Braun-Stiftung
    • CH-4051  Basel
    • Switzerland
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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