The OBSERVE Protocol
Key facts
- Where
- Ann Arbor, Atlanta, Bellaire, Milford, Moore, Nashville, New Haven, and Seattle, United StatesSee the 8 sites
Where in United States
- University of MichiganAnn Arbor, United StatesNo longer taking part
- Emory UniversityAtlanta, United StatesTaking people
- Houston Center for Advanced Psychiatric TreatmentBellaire, United StatesTaking people
- Mood InstituteMilford, United StatesTaking people
- LifeStance HealthMoore, United StatesNo longer taking part
- Athena CareNashville, United StatesTaking people
- Yale School of MedicineNew Haven, United StatesTaking people
- Seattle NTCSeattle, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Yale University
- Trial code
- NCT06725277
- Record updated
- 3 September 2026
- Original description
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.Read full original descriptionShow less
Comparative Effectiveness of Racemic Ketamine Versus Esketamine (Spravato®) for Depression: The OBSERVE Protocol
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.
Inclusion: In order to be eligible to participate in this study, an individual must meet the following criteria:; 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; Scheduled to receive standard clinical treatment 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. These patients are referred to as treatment-initiating subjects; In addition, in order to be eligible, an individual must meet all of the following additional criteria:; Adult ages 18 or older; Provision of signed and dated informed consent form prior to any study procedures; Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion: Diagnosis of bipolar disorder or psychotic disorder (i.e., schizophrenia, schizoaffective disorder); Other psychiatric comorbidities are permitted so long as depression is the predominant diagnosis; Active or recent (within 12 months) substance use disorder (other than nicotine); An individual who meets any of the following criteria will be excluded from participation in this study:.