| NCT ID | NCT06725277 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Major Depression Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-01-21 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 450 participants in total. It began in 2024-01-21 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Samuel Wilkinson, MD
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT06725277 clinical trial?
This trial is open to participants of all sexes, studying Major Depression Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06725277 currently recruiting?
Yes, NCT06725277 is actively recruiting participants. Contact the research team at cynthia.voghell@yale.edu for enrollment information.
Where is the NCT06725277 trial being conducted?
This trial is being conducted at Milford, United States, New Haven, United States, Atlanta, United States, Ann Arbor, United States and 4 additional locations.
Who is sponsoring the NCT06725277 clinical trial?
NCT06725277 is sponsored by Yale University. The principal investigator is Samuel Wilkinson, MD at Yale University. The trial plans to enroll 450 participants.
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