Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Racemic ketamine for Depression

This study wants 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).

Official registry: https://clinicaltrials.gov/study/NCT06713616 · Yale University · enrollment listed as 400

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Racemic ketamine, or Spravato (Esketamine). The registry lists allocation as randomized. This study wants 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).

They plan to enroll about 400 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Comparative Effectiveness of Racemic Ketamine Versus Esketamine (Spravato®) for Depression

Interventions: Racemic ketamine, Spravato (Esketamine)

Primary outcome (registry wording): Self-Reported Effectiveness

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Adults ages 18 or older
  • Diagnosis of major depressive disorder that is refractory to two or more antidepressant trials
  • Moderate or severe depression based on an initial MADRS score ≥ 25
  • Judged appropriate for ketamine or esketamine by clinician, independent of potential study participation
  • A female participant must be:

Public study contact (from the registry)

Cindy Voghell

203-737-4784

Cynthia.Voghell@yale.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

8 listed

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FAQ about this NCT record

Is NCT06713616 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06713616?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06713616?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary