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Novel Esketamine Treatment Shows Promise in Managing Fluctuating Antidepressant Response
A recent pilot randomized clinical trial conducted at Beijing Anding Hospital, Capital Medical University in China, found that esketamine may be an effective, safe treatment for fluctuating antidepressant response in patients with major depressive disorder (MDD).
Researchers published results from the single-center, double-blind trial in JAMA Network Open.
“The simplicity and high success rate of esketamine therapy would allow patients to continue using their current antidepressant regimen and avoid adverse effects associated with changes in the medication regimen,” Chunfeng Xiao, MD, and co-authors wrote in the study. “[F]or example, unanticipated adverse effects and a reduced willingness to seek treatment due to repeated attempts.”
The study, which took place from August 2021 to January 2022, focused on patients aged 18 and older who were experiencing fluctuating symptoms despite stable relief from antidepressant treatment. Of the 30 patients enrolled, 15 received a single subanesthetic dose of esketamine while the remaining 15 received a control treatment with midazolam.
The primary outcome measure was the response rate at 2 weeks, defined as a 50% reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS). Of patients in the esketamine group, 66.7% achieved the desired response, compared to 6.7% in the midazolam group (P < .001). Additionally, participants treated with esketamine exhibited a significantly greater reduction in MADRS score from baseline to 2 weeks compared to the midazolam group (P < .001).
No serious adverse events, psychotogenic effects, or clinically significant manic symptoms were reported in the esketamine group, suggesting a favorable safety profile.
These findings suggest that a single subanesthetic dose of esketamine could enhance the efficacy of oral antidepressants in managing fluctuating antidepressant responses in MDD patients. While further research is needed to confirm these results, this study provides promising insights for clinicians seeking innovative strategies to improve treatment outcomes for their patients with MDD.
Researchers noted several limitations of the study. First, the study used retrospective symptom evaluation with the visual analogue scale (VAS) tool and an empirical definition of fluctuating antidepressant response (FAD), potentially introducing bias. The small, single-center sample also may “limit [the] generalizability of the results,” and including both first-episode and recurrent depression patients may affect validity.
“[C]ollecting data during the COVID-19 pandemic may have impacted the results of this study,” researchers said.” Additionally, a significant difference in dissociation levels at 40 minutes was observed and blinding assessment was lacking, which could potentially affect the integrity of blinding.”
“Based on our findings, it is hypothesized that ketamine or its enantiomer also exerts antidepressant effects via a reticular receptor-associated system involving several antidepressant receptors, which may include interaction with multiple antidepressant receptors,” researchers concluded.
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