Trial document

PLEASE NOTE:
This trial has been registered retrospectively.

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DRKS-ID: 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

DRKS-ID: DRKS00015754
Date of Registration in DRKS: 2018/10/29
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: EA1/123/18, Ethik-Kommission der Charité -Universitätsmedizin Berlin-

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Secondary IDs

Universal Trial Number (UTN): U1111-1219-3028

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Health Condition or Problem studied

ICD10: F32.1 - Moderate depressive episode
ICD10: F32.2 - Severe depressive episode without psychotic symptoms
ICD10: F33.1 - Recurrent depressive disorder, current episode moderate
ICD10: F33.2 - Recurrent depressive disorder, current episode severe without psychotic symptoms

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Interventions/Observational Groups

Arm 1: (Infrared-A-) whole-body hyperthermia with increase in body temperature to 38.5°C
Arm 2: Sham-intervention without increase in body temperature to 38.5°C.

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Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: patient/subject, investigator/therapist
Control: Placebo
Purpose: Treatment
Assignment: Parallel
Phase: N/A
Off-label Drug use: 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

DE: Germany

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Locations of Recruitment

University Medical Center Charité, Berlin

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2018/08/24
Target Sample Size: 82
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- Klinik für Psychiatrie und PsychotherapieCharité Campus Mitte
- Charitéplatz 1
- 10117 Berlin
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Collaborator, Other Address
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- Abt. für Naturheilkunde der Charité
- Mr. Prof. Dr. med. Andreas Michalsen
- Berlin
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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- Klinik für Psychiatrie und Psychotherapie
- Ms. Dr. med. Astrid Knobel
- Charitéplatz 1
- 10117 Berlin
- Germany
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- Telephone: 004930450517347
- Fax: [---]*
- E-mail: astrid.knobel at charite.de
- URL: [---]*
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Contact for Public Queries
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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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- Telephone: 004930450517347
- Fax: [---]*
- E-mail: astrid.knobel at charite.de
- URL: [---]*
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Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)
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- Dr. med. h.c. Erwin-Braun-Stiftung
- CH-4051 Basel
- Switzerland
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Status

Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*

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Trial Publications, Results and other Documents

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