A phase 2 trial of inhaled nitrous oxide for treatment-resistant major depression
| Autor: | Naji C. Salloum, Ben J.A. Palanca, Wayland W.L. Cheng, Robert D. Gibbons, Thomas Nguyen, Helga Komen, Nisha Jain, Alvin M. Janski, Peter Nagele, Charles R. Conway, Britt M. Gott, Jacob D. Bolzenius, Christina N. Lessov-Schlaggar, Charles F. Zorumski, Linda D. Barnes, Frank Brown, Branden Yee, Willa Xiong, Gemma D. Espejo |
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| Rok vydání: | 2020 |
| Předmět: |
Nitrous Oxide
Phases of clinical research Placebo law.invention Persistence (computer science) 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Randomized controlled trial Double-Blind Method law Medicine Humans Adverse effect Depression (differential diagnoses) Depressive Disorder Major Inhalation business.industry Depression General Medicine Nitrous oxide Antidepressive Agents 030227 psychiatry Treatment Outcome chemistry Anesthesia business 030217 neurology & neurosurgery |
| Zdroj: | Science translational medicine. 13(597) |
| ISSN: | 1946-6242 |
| Popis: | Nitrous oxide at 50% inhaled concentration has been shown to improve depressive symptoms in patients with treatment-resistant major depression (TRMD). Whether a lower concentration of 25% nitrous oxide provides similar efficacy and persistence of antidepressant effects while reducing the risk of adverse side effects is unknown. In this phase 2 clinical trial (NCT03283670), 24 patients with severe TRMD were randomly assigned in a crossover fashion to three treatments consisting of a single 1-hour inhalation with (i) 50% nitrous oxide, (ii) 25% nitrous oxide, or (iii) placebo (air/oxygen). The primary outcome was the change on the Hamilton Depression Rating Scale (HDRS-21). Whereas nitrous oxide significantly improved depressive symptoms versus placebo (P = 0.01), there was no difference between 25 and 50% nitrous oxide (P = 0.58). The estimated differences between 25% and placebo were -0.75 points on the HDRS-21 at 2 hours (P = 0.73), -1.41 points at 24 hours (P = 0.52), -4.35 points at week 1 (P = 0.05), and -5.19 points at week 2 (P = 0.02), and the estimated differences between 50% and placebo were -0.87 points at 2 hours (P = 0.69), -1.93 points at 24 hours (P = 0.37), -2.44 points at week 1 (P = 0.25), and -7.00 points at week 2 (P = 0.001). Adverse events declined substantially with dose (P < 0.001). These results suggest that 25% nitrous oxide has comparable efficacy to 50% nitrous oxide in improving TRMD but with a markedly lower rate of adverse effects. |
| Databáze: | OpenAIRE |
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