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NCT06725277Recruiting

The OBSERVE Protocol

Yale University

Start Date

1/21/2024

Completion Date

12/1/2029

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

Age Range: No minimum to No maximum

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)

Interventions

DRUG

Spravato

DRUG

IV Ketamine

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Conditions

Major Depression Disorder

Locations

Mood Institute

Milford, Connecticut 06461

United States

Yale School of Medicine

New Haven, Connecticut 06512

United States

Emory University

Atlanta, Georgia 30322

United States

University of Michigan

Ann Arbor, Michigan 48104

United States

LifeStance Health

Moore, Oklahoma 73160

United States

Athena Care

Nashville, Tennessee 37228

United States

Houston Center for Advanced Psychiatric Treatment

Bellaire, Texas 77401

United States

Seattle NTC

Seattle, Washington 98104

United States