DRKS00004803Completed未知
Hyperthermic baths in patients with depression – effects on symptoms and heart rate variability. A randomized controlled pilot study - Heat: Hyperthermia - an effective antidepressive therapy
ni-Zentrum Naturheilkunde0 sites36 target enrollmentStarted: February 2, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 36
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (—)
- Sex
- All
Inclusion Criteria
- •Age 18 – 65 years
- •male or female
- •Depression (ICD F32/33) lasting longer than 4 weeks confirmed by a physician or psychotherapist
- •Hamilton Depression Scale Total Score =18 and a score =2 Item depressive mood at Screening and Baseline.
- •No change of antidepressant medication during the last 4 weeks and the trial foreseen
Exclusion Criteria
- •pregnancy, lactation, current and serious suicidal or homicidal risk (according to investigator’s judgment), serious concomitant disease (e.g. heart failure, renal failure, lung disease, open wounds), history of seizure disorder, organic mental disorders, alcohol or substance use within the last 6 months prior to the screen visit, schizophrenia, delusional disorder, psychotic disorders, bipolar disorder, antisocial personality disorder, heat urticaria, change of the antidepressive treatment within 4 weeks prior to the screen visit, treatment with beta-blocker or steroids and patients who don`t like hot baths.
Investigators
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