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

What this Trial Is About

Researchers are gathering long-term follow-up information on adults with treatment-resistant major depression who are starting or continuing treatment with either intravenous (IV) ketamine or Spravato, an intranasal form of esketamine. This observational study aims to learn about patient satisfaction, use patterns, long-term effectiveness, and safety of these treatments. The study will take place over five years across six sites including academic medical centers and community psychiatric practices. Participants will be those receiving standard clinical care with either IV ketamine or Spravato as prescribed by their clinicians. The study will observe two groups: patients taking IV ketamine and those using Spravato. Treatments are given as part of usual clinical care, and the study does not assign or change treatments. The primary focus is to compare these two treatment approaches over time. During the study, researchers will collect information at baseline and through six months on treatment satisfaction using the TSQM-9 questionnaire, depression severity reported by patients and clinicians, treatment patterns such as number of treatments, reasons for stopping treatment, average dose, and any adverse events. Participants will be followed for up to five years to provide comprehensive data on these measures and their experiences with treatment.

The OBSERVE Protocol