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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: Recruiting Phase 3 study of Depression, sponsored by Yale University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
defined as the change in depression severity after 8 treatments, as assessed by the 16-item, patient-reported outcome, Quick Inventory of Depression Symptomatology (QIDS-SR16), at the end of one-month of treatment. Scale ranges from 0 - 27 with higher scores indicating worse depression.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2025-01-27 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 3 |
What NCT06713616 shows while recruiting
NCT06713616 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (49% lower).
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 lists 6 locations in 5 states (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.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06713616's enrollment target sits among peer trials
400 107th of 679 higher than 568 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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