PCORI Comparative Effectiveness Study-Esketamine (Spravato) Vs. Ketamine-Equivalence Study

This Phase III, randomised, open-label trial (n=400) will compare the effectiveness, acceptability, and side effects of intravenous ketamine (60mg per dose) and intranasal esketamine (56–84mg per dose) in patients with treatment-resistant depression (TRD).

The study, conducted by Yale University, aims to determine which of the two treatments works better for alleviating symptoms of depression.

Participants, who must have TRD and meet specific criteria, will be randomly assigned to receive either esketamine (Spravato) or intravenous ketamine. Over the course of four weeks, various outcomes will be measured, including changes in depression severity, response rates, and quality of life. The study will also assess patient satisfaction with treatment and track side effects, such as increases in blood pressure or heart rate. This five-year study is expected to provide valuable insights into the relative effectiveness of these two ketamine-based therapies.

Topic Depression Treatment-Resistant Depression
Compound Ketamine
Country United States of America
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Trial Details



Trial Number

Sponsors & Collaborators

Yale University
The Yale Psychedelic Science Group was established in 2016.

Data attribution

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