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RECRUITING
NCT06725277

The OBSERVE Protocol

Sponsor: Yale University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

450

Start Date

2024-01-21

Completion Date

2029-12

Last Updated

2025-05-06

Healthy Volunteers

No

Interventions

DRUG

Spravato

Intranasal esketamine

DRUG

IV 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