The OBSERVE Protocol

NCT06725277 | Recruiting DMC

• 2 other identifiers: 200003867323-005287
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Major Depression Disorder

Outcome Measures

Primary Outcomes (1)

• TSQM-9

  9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9). Analyses will be done for the whole sample as well as for treatment-continuing patients who recently completed a randomized trial of ketamine v. esketamine (EQUIVALENCE). The primary analysis for this measure will analyze treatment-continuing patients. Scores range from 0 - 100 with higher scores indicating higher satisfaction.

  baseline to 6 months

Secondary Outcomes (6)

• Depression Severity (Self Report)

  baseline to 6 months

• Depression Severity (Clinician Report)

  baseline to 6 months

• Measure of Treatment Patterns: Number of treatments

  baseline to 6 months

• Measure of Treatment Patterns: Reasons for Discontinuation

  baseline to 6 months

• Measure of Treatment Patterns: Average Dose

  baseline to 6 months

Study Arms (2)

IV Ketamine

Patients taking IV ketamine

Drug: IV Ketamine

Spravato

Patients taking Spravato, an intranasal form of ketamine

Drug: Spravato

Interventions

Spravato DRUG

Intranasal esketamine

Spravato

IV Ketamine DRUG

IV ketamine

IV Ketamine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population includes adults ages 18 or older with a diagnosis of major depressive disorder that is refractory to two or more antidepressant trials that have moderate to severe depression based on an initial MADRS score of 25 or greater having recently initiated treatment with appropriate baseline measures obtained (treatment-continuing) or scheduled to initiate standard clinical care (treatment-initiating) with either IV ketamine or Spravato® treatment.

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.
• 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)

Sponsors & Collaborators

• Yale University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (6)

Mood Institute

Milford, Connecticut, 06461, United States

RECRUITING

Yale School of Medicine

New Haven, Connecticut, 06512, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48104, United States

RECRUITING

LifeStance Health

Moore, Oklahoma, 73160, United States

RECRUITING

Houston Center for Advanced Psychiatric Treatment

Bellaire, Texas, 77401, United States

RECRUITING

MeSH Terms

Interventions

Esketamine; Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Samuel Wilkinson, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cindy Voghell

CONTACT

203-737-4784; cynthia.voghell@yale.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: January 21, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)