RECRUITING

The OBSERVE Protocol

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Conditions

Major Depression Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Comparative Effectiveness of Racemic Ketamine Versus Esketamine (Spravato®) for Depression: The OBSERVE Protocol

Quick Facts

Study Start:2024-01-21
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06725277

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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.
  2. 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.
  3. 3. Adult ages 18 or older
  4. 4. Provision of signed and dated informed consent form prior to any study procedures
  5. 5. Stated willingness to comply with all study procedures and availability for the duration of the study
  1. 1. Diagnosis of bipolar disorder or psychotic disorder (i.e., schizophrenia, schizoaffective disorder)
  2. 2. Other psychiatric comorbidities are permitted so long as depression is the predominant diagnosis
  3. 3. Active or recent (within 12 months) substance use disorder (other than nicotine)

Contacts and Locations

Study Contact

Cindy Voghell
CONTACT
203-444-7115
cynthia.voghell@yale.edu
Kimberly Vasquez
CONTACT
212-363-0809
kimberly.vasquez@yale.edu

Principal Investigator

Samuel Wilkinson, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale School of Medicine
New Haven, Connecticut, 06512
United States

Collaborators and Investigators

Sponsor: Yale University

  • Samuel Wilkinson, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-21
Study Completion Date2029-12

Study Record Updates

Study Start Date2024-01-21
Study Completion Date2029-12

Terms related to this study

Additional Relevant MeSH Terms

  • Major Depression Disorder