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The OBSERVE Protocol

RecruitingRegisteredCTG

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 (TRD).

Details

A prospective, observational cohort across six US sites enrolling 450 adults with treatment-resistant major depressive disorder receiving either IV ketamine or intranasal esketamine (Spravato) in routine clinical care; follow-up planned for five years to capture real-world effectiveness and safety.

Measures include patient acceptability and satisfaction, patterns of use, long-term clinical outcomes (MADRS), and safety assessments; both treatment-initiating and treatment-continuing patients are eligible.

Topics:Treatment-Resistant Depression (TRD)

Registry

Registry linkNCT06725277