The OBSERVE Protocol

This observational cohort study (n=450) will compare the long-term effectiveness, safety, and patient satisfaction of intravenous (IV) ketamine versus intranasal esketamine (Spravato) for treating major depressive disorder (MDD) that has not responded to at least two antidepressant trials (treatment-resistant depression, TRD).

Conducted over five years across six sites (three academic medical centres and three community psychiatric practices), this study, led by Yale University, aims to assess treatment patterns, adherence, and patient-reported outcomes. Participants will be adults (18+) who have either recently initiated or are about to begin treatment with IV ketamine or Spravato.

The primary outcome will be measured using the 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9), while secondary outcomes include changes in depression severity (measured by the Quick Inventory of Depressive Symptomatology [QIDS] and Montgomery-Åsberg Depression Rating Scale [MADRS]), treatment frequency, dosing patterns, and adverse events. The study is expected to run from January 2024 to December 2029.

Topic Depression Treatment-Resistant Depression Safety
Compound Ketamine
Country United States of America
Visit trial
Status Recruiting
Results Published No
Start date 21 January 2024
End date 01 December 2029
Phase Not Applicable
Design Open
Type Observational
Generation First
Participants 450
Sex All
Age 18- 99
Therapy No

Trial Details

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.

Trial Number NCT06725277

Sponsors & Collaborators

Yale University
The Yale Psychedelic Science Group was established in 2016.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.