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

Not Applicable

Recruiting

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

Registration Number: DRKS00015754

Lead Sponsor: Klinik für Psychiatrie und PsychotherapieCharité Campus Mitte

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 82

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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