Impact of midazolam vs. saline on effect size estimates in controlled trials of ketamine as a rapid-acting antidepressant.

ABSTRACT: The goal of this study was to infer the effectiveness of midazolam as a comparator in preserving the blind in ketamine studies for mood disorders through patient-level analyses of efficacy trial outcomes. In this integrative data analysis (k?=?9, N?=?367 patients with mood disorders), clinical outcomes were compared across four groups: ketamine (midazolam-controlled), ketamine (saline-controlled), midazolam, and saline. Ketamine doses ranged from 0.5 to 0.54?mg/kg and midazolam doses ranged from 0.02 to 0.045?mg/kg. The baseline-to-Day 1 effect size was d?=?0.7 (95% CI: 0.4-0.9) for ketamine (midazolam) versus midazolam and d?=?1.8 (95% CI: 1.4-2.2) for ketamine (saline) versus saline. The effect of ketamine relative to control was larger in saline-controlled studies than in midazolam-controlled studies (t(276)?=?2.32, p?=?0.02). This was driven by a comparatively larger effect under midazolam than saline (t(111)?=?5.40, p?

SUBMITTER: Wilkinson ST 

PROVIDER: S-EPMC6785710 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature