The standard treatment plus intranasal formulation of esketamine V/S standard treatment plus a placebo were compared in a double-blind study to assess the fastest drug to relieve the symptoms of major depression such as suicidal tendency.
‘Esketamine or Ketanest nasal spray can act as a first line rapid-acting drug in the treatment of depression and suicidal tendency. It can be used to reduce depressive symptoms in patients who are assessed to be at the risk of suicide’
Sixty-eight patients were involved in the study, and they were randomly assigned to one of two groups which were either receiving esketamine or placebo twice a week for four weeks.
Antidepressants were given all throughout the study. The results were noted at four hours, 24 hours and 25 days.
The researchers at the Janssen Research and Development and Janssen Scientific Affairs, Titusville, N.J., and San Diego, and the Yale School of Medicine, New Haven, Conn found significant improvement in depression scores and decreased suicidal ideation in the esketamine group when compared to the placebo group at four hours and 24 hours.
These effects in the esketamine group were not greater than the placebo at 25 days. Suicidal risk was also taken into consideration both regarding the patient's and clinician's view.
Esketamine had shown positive results in the treatment of depressive symptoms specifically in patients assessed to be at imminent risk of suicide.
This drug could help bridge the gap that exists because of the delayed effect of common anti-depressants. Most of these anti-depressants take four to six weeks to act.
This was a proof-of-concept, phase 2, study of this drug- esketamine; it still has to complete phase 3 study before it can be presented to FDA for proposal.
More research is needed to apprehend the possibility of ketamine abuse; this has come into focus of an accompanying AJP editorial.
Robert Freedman, AJP Editor, has explained the known potential for abuse and existing reports of abuse of prescribed ketamine. In this article, they discuss the need for further research on abuse potential of ketamine during phase 3 trials.
The AJP Editor's notes that, "protection of the public's health is part of our responsibility as well, and as physicians, we are responsible for preventing new drug epidemics."
Reference
- Carla M. Canuso, Jaskaran B. Singh, Maggie Fedgchin, Pharm.D, Larry Alphs, Rosanne Lane, Pilar Lim, Christine Pinter, David Hough, Gerard Sanacora, Husseini Manji, Wayne C. Drevets.Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study, American Journal of Psychiatry (2018). https://doi.org/10.1176/appi.ajp.2018.17060720
Source: Medindia
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