The OBSERVE Protocol
Recruiting · NCT06725277 · Observational (researchers observe without assigning treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
IV KetamineSpravato
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
- 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 criteria
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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)
Where it is running
8 locations listed across 7 US states.
- Mood Institute - Milford, Connecticut, United States
- Yale School of Medicine - New Haven, Connecticut, United States
- Emory University - Atlanta, Georgia, United States
- University of Michigan - Ann Arbor, Michigan, United States
- LifeStance Health - Moore, Oklahoma, United States
- Athena Care - Nashville, Tennessee, United States
- Houston Center for Advanced Psychiatric Treatment - Bellaire, Texas, United States
- Seattle NTC - Seattle, Washington, United States