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NCT06725277 · ClinicalTrials.gov registry record
The OBSERVE Protocol
A clinical trial of Major Depression Disorder, sponsored by Yale University.
- Recruiting
- Registry status
- 450
- Enrollment target
- 6
- Study locations
NCT06725277: Recruiting study of Major Depression Disorder, sponsored by Yale University.
NCT06725277 is a study of Major Depression Disorder that is actively recruiting participants, run by Yale University. The registered enrollment target is 450 participants. The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06725277, a study of Major Depression Disorder, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- 450 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Spravato
- DRUG IV Ketamine
Study Locations (6)
Connecticut
- Mood Institute - Milford
- Yale School of Medicine - New Haven
Georgia
- Emory University - Atlanta
Michigan
- University of Michigan - Ann Arbor
Oklahoma
- LifeStance Health - Moore
Texas
- Houston Center for Advanced Psychiatric Treatment - Bellaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2024-01-21 |
| Est. Completion | 2029-12 |
What NCT06725277 shows while recruiting
NCT06725277 is an observational study that tracks outcomes without assigning an intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Major Depression Disorder appearing as the primary indexed condition, and to 2 interventions - of which Spravato is the first listed.
NCT06725277 lists 6 locations in 5 states (Connecticut, Georgia, Michigan).
Frequently Asked Questions
What is clinical trial NCT06725277 about?
NCT06725277 is a clinical study titled "The OBSERVE Protocol". 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 ...
What is the current status of trial NCT06725277?
This trial is currently recruiting. The enrollment target is 450 participants. The study started on 2024-01-21. Estimated completion is 2029-12.
What conditions does trial NCT06725277 study?
This clinical trial studies the following conditions: Major Depression Disorder.
What interventions are being tested in trial NCT06725277?
The interventions under investigation include: Spravato (DRUG), IV Ketamine (DRUG).
Who is sponsoring clinical trial NCT06725277?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06725277 being conducted?
This trial has 6 study locations across Connecticut, Georgia, Michigan, Oklahoma, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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