Actively Recruiting
The OBSERVE Protocol
Led by Yale University · Updated on 2025-05-06
450
Participants Needed
6
Research Sites
305 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The OBSERVE Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Recently started treatment (within 75 days) with IV ketamine or Spravato4 prescribed by a clinician for moderate to severe treatment-resistant depression without psychotic features, with baseline measures before treatment
- Scheduled to receive standard clinical treatment with IV ketamine or Spravato4 for moderate to severe treatment-resistant depression without psychotic features
- Adults aged 18 years or older
- Signed and dated informed consent form prior to any study procedures
- Willingness to comply with all study procedures and availability for the study duration
You will not qualify if you...
- Diagnosis of bipolar disorder or psychotic disorder such as schizophrenia or schizoaffective disorder
- Active or recent (within 12 months) substance use disorder other than nicotine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Mood Institute
Milford, Connecticut, United States, 06461
Actively Recruiting
2
Yale School of Medicine
New Haven, Connecticut, United States, 06512
Actively Recruiting
3
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
University of Michigan
Ann Arbor, Michigan, United States, 48104
Actively Recruiting
5
LifeStance Health
Moore, Oklahoma, United States, 73160
Actively Recruiting
6
Houston Center for Advanced Psychiatric Treatment
Bellaire, Texas, United States, 77401
Actively Recruiting
Research Team
C
Cindy Voghell
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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