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

Study comparing Esketamine (Spravato) and Ketamine for effectiveness.

Recruiting
18 years and older
All
Phase 3

This study explores two treatments for treatment-resistant depression (TRD). TRD is when a person with major depression doesn't get better after trying at least two antidepressants. The study looks at *ketamine*, given through an IV (a drip into the arm), and *esketamine* (Spravato®), a nasal spray. Ketamine is not approved by the FDA for TRD, but esketamine is. The study compares how well each treatment works, how comfortable people are using them, and how well they handle any side effects.

To join, you must be 18 or older with TRD. Women who can have babies need to use effective birth control. If you have certain health problems like bipolar disorder, recent substance use issues, or specific heart conditions, you cannot join. The study will last 5 years and involve 400 participants.

  • Participants will be randomly assigned to either ketamine or esketamine groups.
  • You must have someone drive you home after each treatment.
  • Pregnant or breastfeeding women cannot participate.
Study details
    Depression

NCT06713616

Yale University

25 May 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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