Offering hope to many who do not sufficiently respond to existing medications for depression, researchers from the Janssen Research & Development have suggested the efficacy of intranasal esketamine with an antidepressant in the adult population suffering from treatment-resistant depression (TRD).
The study was presented at the annual meeting of the American Psychiatric Association (APA) in May in New York with “statistically significant, clinically meaningful” results.
In comparison to those who received a nasal spray and an oral antidepressant, the study population that received the esketamine spray (56 or 84 mg) exhibited a four-point improvement from baseline up to four weeks when measured on the Montgomery-Åsberg Depression Rating Scale (MADRS). For the drug group, the response rate was 70 percent while the remission rate was 53 percent. Metallic taste, dizziness, nausea and vertigo were the frequently reported adverse side effects. TRD was defined as low or no response to two or more currently available antidepressants of adequate dose and duration in the current stage of depression.
Presenting author Vanina Popova shared that patients who received esketamine doses showed rapid and significant outcomes compared to those who received standard care. She also stated that currently available antidepressants show a MADRS score of only two to three points. According to APA secretary Philip Muskin, this could be an interesting approach to deal with a challenging patient population. He also emphasized the fact that the remission rate was impressive and this is something every physician wants. At the same time, Muskin shared that ketamine comes with psychoactive side effects like dissociation and psychosis; however, the nasal spray form was devoid of any such side effects and was more convenient to use.
An S-enantiomer of ketamine racemate, esketamine received the status of an intranasal drug for the management of TRD in 2013 by the Food and Drug Administration (FDA). In 2016, it was approved for treating major depressive disorder (MDD) with suicidal risk. As per a previous report, administration of 56 mg of esketamine with an oral antidepressant showed a seven-point change from baseline to day 8 while administration of 84 mg showed a 10-point change, compared to those who received placebo. Continuous improvement was evident two months after the treatment.
Different doses of esketamine give clinically significant results
More than 200 patients were enrolled for the study, aged 18 to 64 years, at 39 different sites in United States, Poland, Czech Republic, Germany and Spain. All the participants were intolerant to at least two antidepressants before. The patients were randomly assigned to receive either an open-label antidepressant and intranasal esketamine or an intranasal placebo, between August 2015 and June 2017. They initially received 56mg of esketamine that was gradually increased to 84 mg for a period of four weeks. The researchers found that the primary efficacy endpoint was very high for the active intranasal treatment participants. A rapid response was registered which increased with repeated dosage. Patients receiving esketamine achieved higher remission rates and MDRS score of 12 or less on day 28.
If approved by the FDA, this would be one of the novel treatment approaches for managing TRD in people above 50 years of age. As per Muskin, since the study population comprised only 200 patients, more large-scale studies were required to substantiate the results.
Treating depression in holistic manner
Even though the two studies offer promising results, esketamine nasal spray has a potential to be abused; therefore, it should be taken under the supervision of a trained medical professional. For a person struggling with depression and ketamine addiction, an integrated approach is required to treat the conditions simultaneously. Existence of co-occuring disorders warrants a holistic treatment approach comprising not just non-addictive medication but also counseling, individual and group therapy sessions, and cognitive behavioral therapy.
If you or your loved one is struggling with dual diagnosis, seek immediate help from Sovereign Health, a leading name in mental health and addiction treatment. We offer comprehensive dual diagnosis treatment programs for long-term relief. Call our 24/7 helpline number or chat online with an advisor to locate our best dual diagnosis treatment center.