Trials / Recruiting
RecruitingNCT06725277
The OBSERVE Protocol
Comparative Effectiveness of Racemic Ketamine Versus Esketamine (Spravato®) for Depression: The OBSERVE Protocol
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 450 (estimated)
- Sponsor
- Yale University · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Spravato | Intranasal esketamine |
| DRUG | IV Ketamine | IV ketamine |
Timeline
- Start date
- 2024-01-21
- Primary completion
- 2029-12-01
- Completion
- 2029-12-01
- First posted
- 2024-12-10
- Last updated
- 2025-05-06
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06725277. Inclusion in this directory is not an endorsement.