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
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 December 2024
End date 31 December 2030
Phase Phase III
Design Open
Type Interventional
Generation First
Participants 400
Sex All
Age 18- 99
Therapy No

Trial Details

The purpose of this study is to compare the relative effectiveness, acceptability, and side effects of ketamine delivered through an IV (a drip into the arm) which is not currently FDA approved for use in the treatment of treatment-resistant depression (TRD) and Esketamine (Spravato®), taken as a nasal spray which has received FDA approval for use in the treatment of treatment-resistant depression (TRD) in the treatment of patients with treatment-resistant depression (TRD). The study will look at the following: How well the treatment helps with symptoms of depression (effectiveness), How comfortable and willing people are to use the treatment (acceptability), and How well people can deal with any side effects from the treatment (tolerability). The study will also examine factors that may predict which treatment works better for certain patients.

Trial Number NCT06713616

Sponsors & Collaborators

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

Data attribution

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