NCT06725277Recruiting
The OBSERVE Protocol
Comparative Effectiveness of Racemic Ketamine Versus Esketamine (Spravato®) for Depression: The OBSERVE Protocol
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 450 (estimated)
- First submitted
- 5 Dec 2024
- Start date
- 21 Jan 2024
- Primary completion date
- Dec 2029
- Lead sponsor
- Yale University
- Diseases
- Depression
- NCT number
- NCT06725277
What you commit to
- Study type: Observational
- Planned participants: 450
- From 21 Jan 2024 to the primary completion date, Dec 2029
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Active, not recruiting |
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Houston Center for Advanced Psychiatric Treatment Coordinator of this site? Confirm its status | Bellaire | United States | Recruiting |
| Mood Institute Coordinator of this site? Confirm its status | Milford | United States | Recruiting |
| LifeStance Health Coordinator of this site? Confirm its status | Moore | United States | Active, not recruiting |
| Athena Care Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Yale School of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Seattle NTC Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.