The OBSERVE Protocol

Yale University

Status: Enrolling

Conditions: Major Depression Disorder

Treatments: Drug: Spravato; Drug: IV Ketamine

Study type: Observational

Funder types: Other

Identifiers

NCT06725277

23-005287 (Other Grant/Funding Number)

2000038673

Details and patient eligibility

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.

Enrollment: 450 estimated patients

Sex: All

Volunteers: No 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)

Trial design

450 participants in 2 patient groups

IV Ketamine

Description:

Patients taking IV ketamine

Treatment:

Drug: IV Ketamine

Spravato

Description:

Patients taking Spravato, an intranasal form of ketamine

Treatment:

Drug: Spravato