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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
Conditions
Interventions
Spravato
Intranasal esketamine
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