Trial Profile

SPRAVATO REMS registry

Status: Planning

Phase of Trial: Phase IV

Latest Information Update: 27 Feb 2024

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At a glance

Drugs Esketamine (Primary)
Indications Major depressive disorder
Focus Adverse reactions
Acronyms REMS registry

Most Recent Events

11 Mar 2019 New trial record
05 Mar 2019 According to a Food and Drug Administration media release, drug is only available through a restricted distribution system under this program due to the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug.
05 Mar 2019 REMS (Risk Evaluation and Mitigation Strategy) is a program required by the Food and Drug Administration (FDA). All patients will be enrolled in this study.

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