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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: German Clinical Trials Register
Last refreshed on: 14 January 2019
Main ID:  DRKS00015754
Date of registration: 29/10/2018
Prospective Registration: No
Primary sponsor: Klinik für Psychiatrie und PsychotherapieCharité Campus Mitte
Public title: A randomized, double-blind controlled study of the efficacy of infrared-whole body hyperthermia in patients with major depression
Scientific title: A randomized, double-blind controlled study of the efficacy of infrared-whole body hyperthermia in patients with major depression
Date of first enrolment: 24/08/2018
Target sample size: 82
Recruitment status: Recruiting
URL:  http://www.drks.de/DRKS00015754
Study type:  interventional
Study design:  Allocation: Randomized controlled trial;. Masking: Blinded (patient/subject, investigator/therapist). Control: Placebo. Assignment: Parallel. Study design purpose: Treatment;  
Phase:  N/A
Countries of recruitment
Germany
Contacts
Name: Astrid    Knobel
Address:  Charitéplatz 1 10117 Berlin Germany
Telephone: 004930450517347
Email: astrid.knobel@charite.de
Affiliation:  Klinik für Psychiatrie und Psychotherapie
Name: Astrid    Knobel
Address:  Charitéplatz 1 10117 Berlin Germany
Telephone: 004930450517347
Email: astrid.knobel@charite.de
Affiliation:  Klinik für Psychiatrie und PsychotherapieCharité Campus Mitte
Key inclusion & exclusion criteria
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


Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both, male and female
Health Condition(s) or Problem(s) 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
Intervention(s)
Intervention 1: (Infrared-A-) whole-body hyperthermia with increase in body temperature to 38.5°C Intervention 2: Sham-intervention without increase in body temperature to 38.5°C.
Primary Outcome(s)
HAMD-17 (Hamilton depression scale) score 6 weeks after intervention
Secondary Outcome(s)
- 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)
Secondary ID(s)
EA1/123/18
U1111-1219-3028
Source(s) of Monetary Support
Dr. med. h.c. Erwin-Braun-Stiftung
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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