The OBSERVE Protocol

Recruiting now

Conditions studied: Major Depression Disorder

In brief

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.

Key facts

Study ID

NCT06725277

Run by

Yale University

People needed

450

Starts

2024-01-21

Expected to finish

2029-12-01

Last updated by the study team

2026-07-31

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Mood Institute — Milford, Connecticut, United States (enrolling)
• Yale School of Medicine — New Haven, Connecticut, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Houston Center for Advanced Psychiatric Treatment — Bellaire, Texas, United States (enrolling)
• Seattle NTC — Seattle, Washington, United States (enrolling)
• Athena Care — Nashville, Tennessee, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States
• LifeStance Health — Moore, Oklahoma, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.