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RecruitingPhase 3

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

NCT06713616 · Yale University

Recruiting
Status
Accepting participants
Phase 3
Phase
400
Target enrolment
8
Study sites
7 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Self-Reported Effectiveness

    Measured over 30 days

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Provision of signed and dated informed consent form * 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: a. Not of childbearing potential\*, OR b. Of childbearing potential and practicing a highly effective method of contraception (failure rate of \<1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until 1 week after last dose - the end of relevant systemic exposure. The investigator will evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of drug. Acceptable methods of contraception are: i. combined (estrogen and progestogen containing) hormonal or progestogen-only hormonal contraception associated with inhibition of ovulation (oral, transdermal, or intravaginal) ii. intrauterine device (IUD) iii. intrauterine hormone-releasing system (IUS) iv. bilateral tubal occlusion/ligation v. male partner with a bilateral vasectomy with documented aspermia or a bilateral orchiectomy vi. male or female condom with spermicide, diaphragm, or sponge with spermicide (Note: Use of condom as the sole method of contraception is not considered to be a highly effective method of contraception). * A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study \* We will consider women to be of childbearing potential if they are within 2 years of menopause (within 3 years since last menstrual period) and have not had a hysterectomy, bilateral oophorectomy, or other definitive surgical intervention. Exclusion Criteria: * Diagnosis of bipolar disorder or psychotic disorder (i.e., schizophrenia, schizoaffective disorder) * Other psychiatric comorbidities are permitted so long as depression is the predominant diagnosis * Active or recent (within 12 months) substance use disorder (other than nicotine) * Pregnant or lactating women * Intracerebral hemorrhage or aneurysmal vascular disease * Hypersensitivity to ketamine, esketamine or any of the excipients * Known family history of ketamine use disorder * Prior known ketamine use disorder as well as subjects for whom study participations will result in more than 8 lifetime exposures to ketamine (e.g., prior exposure to ketamine, prior recreational use with ketamine). Prior esketamine exposure is also exclusionary. * Uncontrolled hypertension, as demonstrated by a blood pressure of greater than 145 / 90 at screening visit. (Pre-treatment blood pressure will be permitted to be 150 / 95 to allow for "whitecoat" hypertension on treatment visits 1-8.) * Known cardiovascular and cerebrovascular conditions that are associated with an increased risk related to ketamine or esketamine administration (including space-occupying CNS lesions). This includes those prospective participants who undergo EKG and are shown to have an abnormality that would put them at increased risk related to treatment. * Known condition for which an acute rise in blood pressure would pose a serious risk. * Arteriovenous malformation * Positive urine toxicology at screening visit, except for substances that are prescribed (i.e., benzodiazepines, stimulants). Given the extended length of time between exposure and negative toxicology screen, a positive screen for THC will not be exclusionary unless the pattern of use and clinical evaluation are indicative of cannabis use disorder. Cannabis used within 24 hours of dosing is exclusionary. * Positive alcohol breathalyzer at screening or clinical signs of intoxication * The patient is unable to arrange for someone to drive them home after each treatment session; patients who are unwilling to refrain from driving and operating machinery on treatment days until the next day following sleep will be excluded.

Where

8 study sites

FacilityCityRegionCountry
Mood InstituteMilfordConnecticutUnited States
Yale School of MedicineNew HavenConnecticutUnited States
Emory UniversityAtlantaGeorgiaUnited States
University of MichiganAnn ArborMichiganUnited States
LifeStance HealthMooreOklahomaUnited States
Athena CareNashvilleTennesseeUnited States
Houston Center for Advanced Psychiatric TreatmentBellaireTexasUnited States
Seattle NTCSeattleWashingtonUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06713616 on ClinicalTrials.gov →

Last updated in the registry 2026-07-31. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits