Whole-Body Hyperthermia for the Treatment of Major Depressive Disorder: A Randomized Clinical Trial.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 27172277 · doi:10.1001/jamapsychiatry.2016.1031
What was done
In a 6-week, double-blind, randomized trial, 34 medically healthy, unmedicated adults (aged 18–65 years) with major depressive disorder and a baseline 17-item Hamilton Depression Rating Scale (HDRS) score of 16 or greater were randomized to a single session of active whole-body hyperthermia (WBH) or a matched sham condition. Outcome assessments were conducted by blinded staff over 6 weeks, with 29 participants included in a modified intent-to-treat analysis measuring between-group differences in HDRS scores.
What was found
Active WBH produced statistically significant reductions in HDRS scores compared with sham across the 6-week study: week 1 difference of -6.53 (95% CI, -9.90 to -3.16; P < .001), week 2 difference of -6.35 (95% CI, -9.95 to -2.74; P = .001), week 4 difference of -4.50 (95% CI, -8.17 to -0.84; P = .02), and week 6 difference of -4.27 (95% CI, -7.94 to -0.61; P = .02). Immediately following treatment, 93.8% of the WBH group and 71.4% of the sham group believed they had received active WBH. Adverse events in both arms were generally mild.
Why it matters
This study provides sham-controlled evidence that a single acute session of whole-body hyperthermia can induce rapid and sustained antidepressant effects lasting up to 6 weeks.
Limits
The sample size was very small (29 analyzed out of 34 randomized from 338 screened). The population was limited to medically healthy, unmedicated patients. Blinding may have been imperfect given that 93.8% of the active group correctly identified their assignment compared to 71.4% in the sham group.
Cited by
- supports A 2016 randomized controlled trial by Janssen et al. showed that a single session of whole-body hyperthermia significantly reduced depression symptoms within one week, with the effect maintained across six weeks.
- supports In the 2016 Janssen whole-body hyperthermia trial, approximately 71% of participants in the sham control condition believed they had received the active whole-body hyperthermia treatment.
- supports In a 2013 open-label study by Hanusch et al., the decrease in core body temperature measured over five days following whole-body hyperthermia was correlated with a reduction in depression scores.
- supports In the Janssen 2016 whole-body hyperthermia protocol for depression, participants were heated until reaching a core body temperature of 38.5 °C, after which heating was turned off and core temperature continued rising to approximately 38.85 °C during a one-hour cool-down period.
- supports In clinical trials of whole-body hyperthermia for depression, heating sessions lasted approximately 107 minutes on average in the Janssen protocol and two hours in the Hanusch protocol.