Trial of Ketamine Masked by Surgical Anesthesia in Depressed Patients.
Theresa R LiiAshleigh E SmithJosephine R FlohrRobin L OkadaCynthia A NyongesaLisa J CianfichiLaura M HackAlan F SchatzbergBoris Dov HeifetsPublished in: medRxiv : the preprint server for health sciences (2023)
A single dose of intravenous ketamine compared to placebo has no short-term effect on the severity of depression symptoms in adults with major depressive disorder. This trial successfully masked treatment allocation in moderate-to-severely depressed patients using surgical anesthesia. While it is impractical to use surgical anesthesia for most placebo-controlled trials, future studies of novel antidepressants with acute psychoactive effects should make efforts to fully mask treatment assignment in order to minimize subject-expectancy bias. ( ClinicalTrials.gov number, NCT03861988 ).
Keyphrases
- major depressive disorder
- end stage renal disease
- newly diagnosed
- chronic kidney disease
- phase iii
- clinical trial
- ejection fraction
- bipolar disorder
- study protocol
- phase ii
- double blind
- peritoneal dialysis
- placebo controlled
- squamous cell carcinoma
- prognostic factors
- open label
- high intensity
- extracorporeal membrane oxygenation
- depressive symptoms
- obstructive sleep apnea
- radiation therapy
- aortic dissection
- pain management
- liver failure
- hepatitis b virus
- sleep quality
- drug induced