Spravato or IV Ketamine for Major Depression
The OBSERVE Protocol
Recruiting
Observational Study
Major Depression Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Sex
- Any
- Study type
- Observational
- Participants needed
- 450 (estimated)
- Sponsor
- Yale University · Other
Who this trial is looking for
This trial is looking for adults with major depression who are starting or continuing treatment with Spravato or IV ketamine. Participants will help us learn about the effectiveness and safety of these treatments over a 5-year period.
Are You a Good Fit for This Trial?
You may be able to join if
- I am an adult aged 18 or older
- I have started treatment with Spravato or IV ketamine within the last 75 days
- I am scheduled to receive treatment with Spravato or IV ketamine
- I have moderate to severe depression
- I have tried two or more antidepressants without successful results
- I have provided signed consent to participate in the study
- I am willing to follow all study procedures and be available for the study duration
You may not be able to join if
- I have a diagnosis of bipolar disorder
- I have a diagnosis of a psychotic disorder
- I have a recent substance use disorder within the last 12 months
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About This Trial
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…
Trial Locations
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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 a…
Contacts