Long-term Study Comparing IV Ketamine and Spravato for Treatment-Resistant Depression in Adults

What this Trial Is About

This research aims to provide long-term follow-up data on patients with moderate to severe treatment-resistant depression who are either starting or continuing treatment with IV ketamine or Spravato intranasal esketamine. The study will observe patient acceptability, satisfaction, treatment patterns, long-term effectiveness, and safety of these two approaches. It is an observational study conducted across six sites, including academic medical centers and community psychiatric practices. Participants will be observed over a 5-year period after initiating or continuing treatment with either IV ketamine or Spravato as prescribed by their clinician. Two groups include patients currently receiving IV ketamine and those receiving Spravato. The study collects data on treatment patterns such as the number of treatments, reasons for discontinuation, and average dose during the first 6 months. During the study, participants will provide information through assessments that evaluate treatment satisfaction TSQM-9 and depression severity from both self-report and clinician perspectives. Researchers will also monitor adverse events and treatment patterns from baseline to 6 months. Participants are expected to comply with study procedures and remain available throughout the 5-year follow-up to provide long-term data on treatment outcomes and safety.

The OBSERVE Protocol