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

Part of paid clinical trials in Milford, Connecticut.

Sponsor
Yale University
Study ID
NCT06713616
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Racemic ketamine — DRUG
    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.
  • Spravato (Esketamine) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 27, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Racemic 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.
  • Experimental: Spravato (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.

Primary Outcome Measure

Self-Reported Effectiveness [ Time Frame: 30 days ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Mood InstituteMilfordConnecticut06461
Lisa Harding, MD
[email protected]
203-701-9737
Lisa Harding, MD (PRINCIPAL_INVESTIGATOR)
Yale School of MedicineNew HavenConnecticut06512
Samuel Wilkinson, MD
[email protected]
203-764-9131
Samuel Wilkinson, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Brandon Kitay, MD
404-712-6939
University of MichiganAnn ArborMichigan48104-
LifeStance HealthMooreOklahoma73160
Rachel Dalthorp, MD
[email protected]
Houston Center for Advanced Psychiatric TreatmentBellaireTexas77401
Sandhya Prashad, MD
Sarah Hartigan
[email protected]
(832) 730 - 5196
Sandhya Prashad, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Milford, CT

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Mood Institute· Milford, CTYale School of Medicine· New Haven, CTEmory University· Atlanta, GAUniversity of Michigan· Ann Arbor, MILifeStance Health· Moore, OKHouston Center for Advanced Psychiatric Treatment· Bellaire, TX

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