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The OBSERVE Protocol

NCT06725277 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2025-05-06

No results posted yet for this study

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

Interventions

DRUG

Spravato

Intranasal esketamine

DRUG

IV Ketamine

IV ketamine

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Yale University

    lead OTHER

Principal Investigators

  • Samuel Wilkinson, MD · Yale University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-21
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06725277 on ClinicalTrials.gov