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Repeated-Ketamine Trial’s Final Comparison Included Ketamine in Both Groups After Midazolam Control Infusions
A randomized trial’s earlier and final comparisons answered different questions. Midazolam controls were followed by ketamine in one group, changing the meaning of the primary endpoint.
A randomized trial’s earlier and final comparisons answered different questions. Midazolam controls were followed by ketamine in one group, changing the meaning of the primary endpoint.
The treatment sequence
Participants received either six ketamine infusions or five midazolam infusions followed by one ketamine infusion. Earlier comparisons favored repeated ketamine before the second group received ketamine.
At twenty-four hours after the last infusion, the primary depression-score difference was not statistically significant. Nominal differences in relapse timing were also uncertain.
Retain the endpoint schedule
The final result was not a six-ketamine-versus-six-midazolam comparison. The study was underpowered for the primary difference, and the active-control design did not resolve every blinding concern.
It cannot establish that repeated treatment has no benefit, nor can earlier superiority be substituted for primary-endpoint success. A forensic or clinical summary should retain the full infusion sequence, comparison time, outcome definition, and uncertainty rather than describing midazolam as the sole exposure throughout the control course.
Source paper
Original analysis of the supplied journal article, identified as PMC7319954.