Clinical trial NCT06725277: The OBSERVE Protocol
Official title: Comparative Effectiveness of Racemic Ketamine Versus Esketamine (Spravato®) for Depression: The OBSERVE Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Major Depression Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2024-12-10
Enrollment: 450
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population includes adults ages 18 or older with a diagnosis of major depressive disorder that is refractory to two or more antidepressant trials that have moderate to severe depression based on an initial MADRS score of 25 or greater having recently initiated treatment with appropriate baseline measures obtained (treatment-continuing) or scheduled to initiate standard clinical care (treatment-initiating) with either IV ketamine or Spravato® treatment.

Brief 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 criteria: 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 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

Exclusion Criteria:

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)

Primary outcomes:
measure: TSQM-9
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Depression Severity (Self Report)
timeFrame: baseline to 6 months
measure: Depression Severity (Clinician Report)
timeFrame: baseline to 6 months
measure: Measure of Treatment Patterns: Number of treatments
timeFrame: baseline to 6 months
measure: Measure of Treatment Patterns: Reasons for Discontinuation
timeFrame: baseline to 6 months
measure: Measure of Treatment Patterns: Average Dose
timeFrame: baseline to 6 months
measure: Measures of Adverse Events
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Milford
country: United States
facility: Mood Institute
state: Connecticut
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Moore
country: United States
facility: LifeStance Health
state: Oklahoma
city: Bellaire
country: United States
facility: Houston Center for Advanced Psychiatric Treatment
state: Texas
Study officials:
affiliation: Yale University
name: Samuel Wilkinson, MD
role: PRINCIPAL_INVESTIGATOR
References: