Trial document
This trial has been registered retrospectively.
DRKS00015754
Trial Description
Title
A randomized, double-blind controlled study of the efficacy of infrared-whole body hyperthermia in patients with major depression
Trial Acronym
GKH-D
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.
Do you plan to share individual participant data with other researchers?
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Description IPD sharing plan:
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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-
Secondary IDs
- U1111-1219-3028
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
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.
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- patient/subject, investigator/therapist
- Placebo
- Treatment
- Parallel
- N/A
- N/A
Primary Outcome
HAMD-17 (Hamilton depression scale) score 6 weeks after intervention
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)
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Actual
- 2018/08/24
- 82
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 65 Years
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
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
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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- astrid.knobel at charite.de
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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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- astrid.knobel at charite.de
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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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