Safety, effectiveness and tolerability of sublingual ketamine in depression and anxiety: A retrospective study of off-label, at-home use

This at-home open-label study (n=664) finds that ketamine tablets were safe to use and significantly reduced both depression and anxiety. On both measures, 48% of patients had a significant reduction (>50% drop in score); this increased for those receiving three additional doses (n=210).

Abstract

“Intravenous and intranasal ketamine have been shown to be effective therapeutic options in patients suffering from treatment-resistant depression (TRD). The use of sublingual (SL), rapid dissolve ketamine tablets (RDT) offers a novel approach for delivery for mental health indications. This study assessed the effectiveness and safety of self-administration of off-label, SL, rapid dissolve ketamine tablets (RDT) at-home for depression and anxiety. Intake scores on the Generalized Anxiety Disorder Screener (GAD-7) and Patient Health Questionnaire (PHQ-9) were compared to scores after treatments of three doses of ketamine RDT, and after six doses of ketamine RDT. After three doses of SL ketamine, 47.6% of patients showed a significant decrease in PHQ-9 scores, and 47.6% of patients showed a significant reduction in GAD-7 scores. Reduction rates were higher in those patients who completed a clinically recommended six doses of RDT ketamine. This study demonstrates that SL ketamine is a novel, safe, and effective treatment for TRD and treatment-resistant anxiety. SL ketamine offers an alternative therapeutic approach to IV ketamine when treating those with TRD.”

Authors: Kazi Hassan, William M. Struthers, Aditya Sankarabhotla & Patrick Davis

Summary of Safety, effectiveness and tolerability of sublingual ketamine in depression and anxiety

Introduction

Major Depressive Disorder (MDD) is a common psychiatric condition that affects nearly 350 million people globally. Treatment of MDD with antidepressants effectively alleviates symptoms in approximately 50% of patients.

Clinicians have long recognized that anxiety disorders may be comorbid with depression and that benzodiazepines may interfere with the use of ketamine in patients with TRD. Comorbid anxiety disorders are also associated with a greater severity of depressive symptoms and an increased time to recovery.