Journal of psychiatric research
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Multicenter Study Comparative Study
Comparability of blinded remote and site-based assessments of response to adjunctive esketamine or placebo nasal spray in patients with treatment resistant depression.
Functional unblinding due to treatment emergent adverse events (TEAEs) may occur with any investigational drug and poses a challenge for double-blind, placebo-controlled studies. This pilot study compared site-based Montgomery-Asberg Depression Rating Scale (MADRS) scores to remote, site-independent scores by blinded raters. Audio-digital recordings of site-based MADRS interviews were obtained from a subset of patients during a double-blind, placebo-controlled study of esketamine nasal spray or placebo spray in treatment resistant depression (Clinical Trials Registration: NCT01998958). ⋯ The remote site-independent raters essentially replicated the site-based MADRS scores and yielded a 92.9% predictive value for matching treatment response and remission rates. This small pilot study affirms that blinded remote ratings (without the likelihood of functional unblinding) are comparable to site-based ratings of efficacy of esketamine nasal spray. The audio-digital recording method offers a reasonable strategy for other studies that may also be vulnerable to functional unblinding due to distinctive TEAEs.
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Opioid misuse is a significant public health problem. Chronic pain is one highly prevalent factor that is strongly associated with increased risk for opioid misuse. ⋯ Results indicated that anxiety sensitivity total score was significantly associated with the relationship between pain intensity and current opioid misuse, as well as pain intensity and severity of opioid dependence. Overall, results suggest that anxiety sensitivity may be an important assessment and intervention target to ultimately reduce the rates of opioid misuse among adults with chronic pain.