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Spravato (Esketamine) / Racemic ketamine / Depression · Phase 3 Trial
ClinicalTrials.gov · September 8, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered phase 3 comparative effectiveness trial, currently recruiting, that will compare intravenous racemic ketamine with intranasal esketamine (Spravato) in treatment-resistant depression. No results have yet been posted to the registry, and the study's findings remain pending.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Depression; age from 18 Years. Intervention: Racemic Ketamine; Spravato (Esketamine). Compared with: Esketamine (Spravato) administered as nasal spray. n = 400. 8 sites: United States.
This is a registered phase 3 comparative effectiveness trial, currently recruiting, that will compare intravenous racemic ketamine with intranasal esketamine (Spravato) in treatment-resistant depression. No results have yet been posted to the registry, and the study's findings remain pending.
This is a registry record only; no efficacy or safety results have been posted. No secondary endpoints, safety monitoring plan, or analytical approach is detailed in the registry summary.
When results are available, this head-to-head comparison will help clinicians and patients understand the relative effectiveness, acceptability, and tolerability of two ketamine formulations for TRD. The trial is designed to identify patient factors that predict better response to one agent over the other.
This is a phase 3 trial registration with no posted results; the study is actively recruiting and has not yet generated outcome data.
As stated by the source record.
Quoted from the source exactly as published.
When results are available, this head-to-head comparison will help clinicians and patients understand the relative effectiveness, acceptability, and tolerability of two ketamine formulations for TRD. The trial is designed to identify patient factors that predict better response to one agent over the other.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06713616). This is a study registration, not published results. Lead sponsor: Yale University. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 400 participants (ESTIMATED). Conditions: Depression. Interventions: DRUG: Racemic ketamine; DRUG: Spravato (Esketamine). Primary outcome measures: Self-Reported Effectiveness , 30 days. Brief summary: 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.