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The use of blinded remote site-independent ratings of response to treatment efficacy of adjunctive esketamine nasal spray or placebo was found to be comparable to site-based assessments of efficacy in patients with treatment-resistant depression, according to study results published in the Journal of Psychiatric Research.
Researchers conducted a pilot study that included a randomly selected subset of participants (n=14) from an ongoing double-blind placebo-controlled study examining the efficacy and safety of esketamine nasal spray in patients with treatment-resistant depression. In order to assess the risk for functional unblinding often seen with investigational agents, the team used digital audio recordings to compile blinded remote ratings of drug efficacy, which were then compared with site-based response scores measured using the Montgomery-Asberg Depression Rating Scale.
After analysis, the researchers found that the remote response ratings produced a 92.9% predictive value for equating response and remission rate, which suggested that both methods were comparable. Furthermore, the investigators reported that the blinded remote ratings did not carry any risk for functional unblinding.
The primary study limitation was the small sample size. However, the researchers stated, “This…pilot study affirms the utility of remote, site-independent ratings to monitor and assure site-based rater quality.”
“The [blinded remote rating] method offers a reasonable strategy for other studies that may also be vulnerable to functional unblinding,” they concluded.
Reference
Targum SD, Daly E, Fedgchin M, Cooper K, Singh JB. Comparability of blinded remote and site-based assessments of response to adjunctive esketamine or placebo nasal spray in patients with treatment resistant depression. J Psychiatr Res. 2019;111:68-73.
