Comparative Effectiveness of Racemic Ketamine Versus Esketamine (Spravato®) for Depression: The OBSERVE Protocol
Yale University
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
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet the following criteria: 1. Recently started treatment (within 75 days of screening visit) with IV ketamine or Spravato® as prescribed by a clinician for the treatment of moderate to severe (based on an initial MADRS score ≥ 25) TRD (refractory to two or more antidepressant trials) without psychotic features and having appropriate baseline measures collected before starting treatment. These patients are referred to as treatment-continuing subjects. OR 2. Scheduled to receive standard clinical…
Interventions
- DrugSpravato
Intranasal esketamine
- DrugIV Ketamine
IV ketamine
Locations (6)
- Mood InstituteMilford, Connecticut
- Yale School of MedicineNew Haven, Connecticut
- Emory UniversityAtlanta, Georgia
- University of MichiganAnn Arbor, Michigan
- LifeStance HealthMoore, Oklahoma
- Houston Center for Advanced Psychiatric TreatmentBellaire, Texas