drugset / Trial / NCT03748446
Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder
Non-randomizedCrossoverTriple-blindTreatment
Summary
The investigators will test the hypothesis that inhaled xenon will produce a rapid improvement in depressive symptoms in patients suffering from treatment-resistant depression. Specifically, the investigators will conduct a parallel randomized, double-blind crossover study that will compare the effects of xenon-oxygen (35:65 ratio by volume) added to treatment as usual (X-TAU group) to the effects of nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual (N-TAU group). A total of 20 severely depressed patients, 10 with major depressive disorder (MDD) and 10 with Bipolar Depression (BP), will be exposed in random order to N-TAU and X-TAU in a double-blind protocol.
Timeline
- Start
- 2019-12-05
- Primary completion
- 2026-09-01
- Completion
- 2026-12-01
Publications
- Background Bedi A, McCarroll C, Murray JM, Stevenson MA, Fee JP. The effects of subanaesthetic concentrations of xenon in volunteers. Anaesthesia. 2002 Mar;57(3):233-41. doi: 10.1046/j.0003-2409.2001.02455.x.
- Background Gaynes BN, Warden D, Trivedi MH, Wisniewski SR, Fava M, Rush AJ. What did STAR*D teach us? Results from a large-scale, practical, clinical trial for patients with depression. Psychiatr Serv. 2009 Nov;60(11):1439-45. doi: 10.1176/ps.2009.60.11.1439.
- Background Goto T, Nakata Y, Ishiguro Y, Niimi Y, Suwa K, Morita S. Minimum alveolar concentration-awake of Xenon alone and in combination with isoflurane or sevoflurane. Anesthesiology. 2000 Nov;93(5):1188-93. doi: 10.1097/00000542-200011000-00009.
- Background Kendall T, Morriss R, Mayo-Wilson E, Meyer TD, Jones SH, Oud M, Baker MR. NICE guidance on psychological treatments for bipolar disorder. Lancet Psychiatry. 2016 Apr;3(4):317-20. doi: 10.1016/S2215-0366(16)00082-1. No abstract available.
- Background Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, Rush AJ, Walters EE, Wang PS; National Comorbidity Survey Replication. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). JAMA. 2003 Jun 18;289(23):3095-105. doi: 10.1001/jama.289.23.3095.
- Background Krystal JH, Karper LP, Seibyl JP, Freeman GK, Delaney R, Bremner JD, Heninger GR, Bowers MB Jr, Charney DS. Subanesthetic effects of the noncompetitive NMDA antagonist, ketamine, in humans. Psychotomimetic, perceptual, cognitive, and neuroendocrine responses. Arch Gen Psychiatry. 1994 Mar;51(3):199-214. doi: 10.1001/archpsyc.1994.03950030035004.
- Background Kupfer DJ, Frank E, Phillips ML. Major depressive disorder: new clinical, neurobiological, and treatment perspectives. Lancet. 2012 Mar 17;379(9820):1045-55. doi: 10.1016/S0140-6736(11)60602-8. Epub 2011 Dec 19.
- Background Ma D, Wilhelm S, Maze M, Franks NP. Neuroprotective and neurotoxic properties of the 'inert' gas, xenon. Br J Anaesth. 2002 Nov;89(5):739-46.
- Background Yonas H, Grundy B, Gur D, Shabason L, Wolfson SK Jr, Cook EE. Side effects of xenon inhalation. J Comput Assist Tomogr. 1981 Aug;5(4):591-2. doi: 10.1097/00004728-198108000-00029.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Xenon | Other / unclassified | 35 % | Inhaled |