New research suggests a nasal spray formulation of ketamine may be an option for the rapid treatment of symptoms of major depression and suicidal thoughts.
In a double-blind study, investigators compared treatment protocols for an individual presenting with major depression and imminent suicidal thoughts.
The standard care for this mental condition was compared to an intervention that added an intranasal formulation of esketamine, part of the ketamine molecule, in addition to standard protocol.
The study, involving 68 randomly assigned participants, appears online in The American Journal of Psychiatry (AJP).
Participants were assigned to assigned to one of two groups – either receiving esketamine or placebo twice a week for four weeks. All participants continued to receive treatment with antidepressants throughout. The researchers looked at effects at four hours after first treatment, at 24 hours and at 25 days.
Researchers found a significant improvement in depression scores and decreased suicidal ideation in the esketamine group compared to the placebo group at four hours and at 24 hours. The esketamine effects were not greater than the placebo at 25 days.
The measurement of suicide risk took into consideration both the patient’s and clinician’s perspectives.
Investigators believe the results of the study support the use of a nasal spray of esketamine for rapid treatment of depressive symptoms in patients assessed to be at imminent risk for suicide.
The use of esketamine could be an important intervention for people with acute depression. Currently, most antidepressants take four to six weeks to become fully effective. Therefore, esketamine could potentially help bridge this pharmacological gap in clinical effectiveness.
This study was a proof-of-concept, phase 2, study for esketamine; it must still go through a phase 3 study before possible FDA approval. The research was funded by Janssen Research and Development, LLC.
The authors caution that more research is needed on the potential for abuse of ketamine. That caution is also the focus of an accompanying AJP editorial also published online.
In the editorial, AJP Editor Robert Freedman, M.D., along with members of the AJP Editorial Board, note the known potential for abuse and existing reports of abuse of prescribed ketamine.
They discuss the need for additional research relating to the abuse potential of ketamine during phase 3 trials, such as monitoring of patients’ craving and potential ketamine use from other sources.
While it is the responsibility of physicians to provide a suicidal patient with the fullest range of effective interventions, the AJP editors note, “protection of the public’s health is part of our responsibility as well, and as physicians, we are responsible for preventing new drug epidemics.”
The editors suggest the need for broad input in the development of effective controls on the distribution and use of ketamine.
Freedman and colleagues argue that steps to control the use of ketamine would not be aimed at preventing its use for beneficial purposes but would allow for treatment to “continue to be available to those with need, while the population that is at-risk for abuse is protected from an epidemic of misuse.”