Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06713616

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

Led by Yale University · Updated on 2026-05-05

400

Participants Needed

6

Research Sites

309 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

P

Patient-Centered Outcomes Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form provided
  • Willingness to comply with all study procedures and available for the study duration
  • Adults aged 18 years or older
  • Diagnosed with major depressive disorder resistant to two or more antidepressant trials
  • Moderate or severe depression with an initial MADRS score of 25 or higher
  • Clinician judgment that ketamine or esketamine treatment is appropriate
  • Female participants must either not be of childbearing potential or use a highly effective contraception method and agree to continue it during treatment and for 1 week after last dose
  • Female participants must agree not to donate eggs or freeze them for assisted reproduction during the study
  • Women considered of childbearing potential are within 2 years of menopause and have not had certain surgical procedures like hysterectomy or bilateral oophorectomy
Not Eligible

You will not qualify if you...

  • Diagnosis of bipolar disorder or psychotic disorders (e.g., schizophrenia, schizoaffective disorder)
  • Active or recent substance use disorder within 12 months, except nicotine
  • Pregnant or lactating women
  • Intracerebral hemorrhage or aneurysmal vascular disease
  • Hypersensitivity to ketamine, esketamine, or any ingredients
  • Known personal or family history of ketamine use disorder
  • Prior ketamine use disorder or more than 8 lifetime ketamine exposures
  • Prior esketamine exposure
  • Uncontrolled hypertension (blood pressure over 145/90 at screening)
  • Cardiovascular or cerebrovascular conditions increasing risk with ketamine or esketamine
  • Conditions where acute blood pressure rise is dangerous
  • Arteriovenous malformation
  • Positive urine toxicology at screening except prescribed substances; recent cannabis use within 24 hours is exclusionary
  • Positive alcohol breath test or signs of intoxication at screening
  • Unable or unwilling to have someone drive home after treatment or refrain from driving until next day

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 6 locations

1

Mood Institute

Milford, Connecticut, United States, 06461

Actively Recruiting

2

Yale School of Medicine

New Haven, Connecticut, United States, 06512

Actively Recruiting

3

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

4

University of Michigan

Ann Arbor, Michigan, United States, 48104

Active, Not Recruiting

5

LifeStance Health

Moore, Oklahoma, United States, 73160

Actively Recruiting

6

Houston Center for Advanced Psychiatric Treatment

Bellaire, Texas, United States, 77401

Actively Recruiting

Loading map...

Research Team

C

Cindy Voghell

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here