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

StatusRecruiting
PhasePhase 3
Started2025-01-27
View on ClinicalTrials.gov ↗

Amendment history

2026-09-02
Study Status, Contacts/Locations v9
Study sitescontacts updated at 1 of 8 sites
2026-07-29
Study Status, Contacts/Locations v8
Study sites6→8
2026-04-29
Study Status, Eligibility, Contacts/Locations v7
Eligibility criteria+49 characters
[...] exposure to ketamine, prior recreational use with ketamine). Prior esketamine exposure is also exclusionary. Uncontrolled hypertension, as demonstrated by a blood pressu [...]
Study sitesdetails revised at 1 of 6 sites
2026-02-12
Study Status, Oversight v6
Re-verified, no change to tracked fields
2025-05-14
Study Status, Contacts/Locations v5
Study sites4→6
Show 4 earlier versions
2025-03-12
Study Identification, Study Status, Contacts/Locations v4
Study sitescontacts updated at 3 of 4 sites
Study titlerevised
PCORI Comparative Effectiveness Study-Esketamine (Spravato) Vsvs. Ketamine-Equivalence Study
2025-02-26
Study Status, Contacts/Locations v3
Study sites3→4
2025-02-19
Study Status, Contacts/Locations v2
Re-verified, no change to tracked fields
2025-02-14
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-12-01→confirmed 2025-01-27
Study sites1→3
2024-11-27
Original filing
Yale University
487 trials monitored
See 35 trials at risk
Depression
2,976 trials monitored
See 162 trials at risk
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 Details
NCT Number NCT06713616
Lead Sponsor Yale University
Collaborators: Patient-Centered Outcomes Research Institute
Conditions Depression
Enrollment 400 participants
Start Date 2025-01-27
Primary Completion 2030-12-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-08