RecruitingNCT06725277

The OBSERVE Protocol

Comparative Effectiveness of Racemic Ketamine Versus Esketamine (Spravato®) for Depression: The OBSERVE Protocol

Sponsor

Yale University

Enrollment

450 participants

Start Date

Jan 21, 2024

Study Type

OBSERVATIONAL

Conditions

Major Depression Disorder

Summary

This observational protocol is intended to provide long-term follow-up data on patients initiating or continuing treatment with either Spravato® or IV ketamine. This can provide us information on the patient acceptability and satisfaction, patterns of use, long-term effectiveness, and safety of the two approaches. This 5-year, 6-site study will enroll 450 total patients. The sites will comprise 3 academic medical centers and 3 community psychiatric practices.

Eligibility

Plain Language Summary

Simplified for easier understanding

This study observes patients who recently started treatment with IV ketamine or Spravato (esketamine nasal spray) for moderate-to-severe depression to track how their symptoms change over time and understand what factors predict response. **You may be eligible if...** - Recently started treatment with IV ketamine or Spravato nasal spray (within 75 days of the screening visit) - Treatment was prescribed by a clinician for moderate-to-severe depression - Willing to complete assessments and follow-up visits **You may NOT be eligible if...** - You are not currently receiving IV ketamine or Spravato treatment - Your ketamine/Spravato treatment was not prescribed for depression - You are unable to complete study assessments 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.

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Interventions

DRUGSpravato

Intranasal esketamine

DRUGIV Ketamine

IV ketamine

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

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NCT06725277

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