A nasal spray formulation of ketamine shows the promise of rapid treatment of symptoms of major depression and suicidal ideation, according to a new study published online today in The American Journal of Psychiatry ( AJP ).
The double blind study compared the standard treatment plus an intranasal formulation of esketamine, a part of the ketamine molecule, for standard treatment plus a placebo for rapid treatment of symptoms of major depression, including suicidality among subjects with transient suicide risk. The study included 68 participants randomized to one of two groups ̵
The study was conducted by researchers at Janssen Research and Development and Janssen Scientific Affairs, Titusville, NJ and San Diego and Yale School of Medicine, New Haven, Conn. They found a significant improvement in depression scores and reduced suicidal ideation in the esketamine group versus the placebo group in four hours and at 24 hours. Esketamin effects were no greater than placebo at 25 days. The measurement of suicidal risk took into account the patient and clinician's perspective.
The results of the study support nasal spray esketamine as a possible effective rapid treatment for depressive symptoms in patients considered to be imminent risk of suicide, according to the author. Esketamine may be an important treatment for bridging the gap that occurs due to the delayed effect of common antidepressants. Most antidepressants take four to six weeks to become fully effective.
This study was a proof of concept, phase 2, study for esketamine; It must still go through a Phase 3 study before any FDA approval. It was funded by Janssen Research and Development, LLC.
The authors warn that more research is needed about the potential for addiction to ketamine. That warning is also the focus of an accompanying AJP editorial that is also published online today. In the editors, the AJP editor notes Robert Freedman, M.D. together with the members of the AJP Editorial Committee, the known potential for abuse and existing reports of abuse of prescribed ketamine. They discuss the need for further research on the abuse potential of ketamine during Phase 3 trials, such as patient monitoring and potential ketamine use from other sources.
While it is the responsibility of doctors to provide a suicide patient with the full range of effective efforts, the AJP editor's remark, "The protection of public health is also part of our responsibility, and as a physician we are responsible for preventing new drug epidemics. " The editors suggest the need for broad entry in the development of effective controls on the distribution and use of ketamine.
Freedman and colleagues claim that measures to control the use of ketamine would not focus on preventing the use of that for beneficial purposes but would allow treatment to "continue to be available to those with needs while protecting the population at risk of abuse" from an epidemic of abuse ".
Esketamin safe, effective for treatment-resistant depression
American Journal of Psychiatry (2018). DOI: 10.1176 / appi.ajp.2018.17060720