Skip to content
RecruitingN/A

The OBSERVE Protocol

NCT06725277 · Yale University

Recruiting
Status
Accepting participants
Not applicable
Phase
450
Target enrolment
8
Study sites
7 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • TSQM-9

    Measured over baseline to 6 months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

Not stated
Ages
All
Sex
Not accepted
Healthy volunteers
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)

Where

8 study sites

FacilityCityRegionCountry
Mood InstituteMilfordConnecticutUnited States
Yale School of MedicineNew HavenConnecticutUnited States
Emory UniversityAtlantaGeorgiaUnited States
University of MichiganAnn ArborMichiganUnited States
LifeStance HealthMooreOklahomaUnited States
Athena CareNashvilleTennesseeUnited States
Houston Center for Advanced Psychiatric TreatmentBellaireTexasUnited States
Seattle NTCSeattleWashingtonUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06725277 on ClinicalTrials.gov →

Last updated in the registry 2026-07-31. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits