RecruitingMajor Depression Disorder
The OBSERVE Protocol
Eligible age
All ages
Accepts
All genders
Locations
5 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Yale University
You may qualify if…
- ✓ 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 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:
- ✓ 3. Adult ages 18 or older
- ✓ 4. Provision of signed and dated informed consent form prior to any study procedures
- ✓ 5. Stated willingness to comply with all study procedures and availability for the duration of the study
You may not qualify if…
- ✕ An individual who meets any of the following criteria will be excluded from participation in this study:
- ✕ 1. Diagnosis of bipolar disorder or psychotic disorder (i.e., schizophrenia, schizoaffective disorder)
- ✕ 2. Other psychiatric comorbidities are permitted so long as depression is the predominant diagnosis
- ✕ 3. Active or recent (within 12 months) substance use disorder (other than nicotine)
Where it's recruiting
Source: ClinicalTrials.gov · NCT06725277 · last updated 2025-05-06