The OBSERVE Protocol
ConditionMajor Depression Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorYale University
About this trial
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 criteria
Qualifiers
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.
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.
Adult ages 18 or older
Provision of signed and dated informed consent form prior to any study procedures
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Spravato
- IV Ketamine
Treatment groups
450 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov