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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00015754

Enrollment

Registered

2018-10-29

Start date

2018-08-24

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F32.1 F32.2 F33.1 F33.2

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
HAMD-17 (Hamilton depression scale) score 6 weeks after intervention	—

Secondary

Measure	Time frame
- 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)	—

Measure

Time frame

- 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

Germany

Contacts

Public ContactAstrid Knobel

Klinik für Psychiatrie und PsychotherapieCharité Campus Mitte

astrid.knobel@charite.de004930450517347

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026