RecruitingPhase 3NCT06713616

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

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

Sponsor

Yale University

Enrollment

400 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

Depression

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This comparative effectiveness study evaluates whether esketamine (Spravato, a nasal spray) and ketamine (an IV infusion) work equally well for treatment-resistant depression — meaning depression that hasn't improved with at least two antidepressant medications. **You may be eligible if...** - You are 18 or older - You have major depressive disorder that did not improve after trying at least two different antidepressants - Your current depression is moderate to severe (MADRS score of 25 or higher) - Your doctor has already determined that ketamine or esketamine is appropriate for you - Women of childbearing potential must use effective contraception **You may NOT be eligible if...** - Your depression has not been confirmed as treatment-resistant - Your depression score is below the threshold required - Your doctor does not consider ketamine or esketamine appropriate for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRacemic ketamine

Ketamine will be given intravenously. Per FDA guidance, the max dose of ketamine will be 60mg per day, with a total lifetime limit of 8 doses. Ketamine will be infused over 40 minutes.

DRUGSpravato (Esketamine)

Spravato® (Esketamine) will be given intranasally. For esketamine, the dose will be between 56 and 84mg, according to the FDA label for the drug. Allowances will be made for patients who have difficulty tolerating these doses to be dosed at 28mg in subsequent treatment sessions.

Locations(6)

Mood Institute

Milford, Connecticut, United States

Yale School of Medicine

New Haven, Connecticut, United States

Emory University

Atlanta, Georgia, United States

University of Michigan

Ann Arbor, Michigan, United States

LifeStance Health

Moore, Oklahoma, United States

Houston Center for Advanced Psychiatric Treatment

Bellaire, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06713616

Related Trials

Suubi-Mhealth: A Mobile Health Intervention to Address Depression Among Youth

NCT059652452 locations

Probiotic Treatment for Depression and Associated Mood Disorders in Parkinson's Disease

NCT055684981 location