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NCT06713616 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Depression, sponsored by Yale University.

Recruiting
Registry status
Phase 3
Development phase
400
Enrollment target
6
Study locations

NCT06713616 is a Phase 3 study of Depression that is actively recruiting participants, run by Yale University. The registered enrollment target is 400 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (49% lower). The trial reports 6 study locations across 5 states.

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The verdict

NCT06713616, a Phase 3 study of Depression, is actively recruiting participants, sponsored by Yale University.

RECRUITING
Registry status
Phase 3
Development phase
400 participants
Enrollment target
6
Study locations

Study 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.

Conditions Studied

Depression

Interventions

  • DRUG Racemic ketamine
  • DRUG Spravato (Esketamine)

Study Locations (6)

Connecticut

  • Mood Institute - Milford
  • Yale School of Medicine - New Haven

Georgia

  • Emory University - Atlanta

Michigan

  • University of Michigan - Ann Arbor

Oklahoma

  • LifeStance Health - Moore

Texas

  • Houston Center for Advanced Psychiatric Treatment - Bellaire

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2025-01-27
Est. Completion 2030-12-31
Phase Phase 3

Sponsor

Yale University

1,492 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06713616

The ClinicalTrials.gov registry entry for NCT06713616 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (49% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Racemic ketamine is the first listed.

NCT06713616 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Connecticut, Georgia, Michigan.

Frequently Asked Questions

What is clinical trial NCT06713616 about?

NCT06713616 is a clinical study titled "PCORI Comparative Effectiveness Study-Esketamine (Spravato) vs. Ketamine-Equivalence Study". 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 na...

What is the current status of trial NCT06713616?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2025-01-27. Estimated completion is 2030-12-31.

What conditions does trial NCT06713616 study?

This clinical trial studies the following conditions: Depression.

What interventions are being tested in trial NCT06713616?

The interventions under investigation include: Racemic ketamine (DRUG), Spravato (Esketamine) (DRUG).

Who is sponsoring clinical trial NCT06713616?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06713616 being conducted?

This trial has 6 study locations across Connecticut, Georgia, Michigan, Oklahoma, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.