drugset / Trial / NCT05450432

Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression

NCT05450432

NaSingle-groupOpen-labelTreatment

Summary

The study will consist of a 24-week-long trial examining outcomes in patients with Major Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and intranasal (IN) esketamine, compared to a large sample of matched historical controls. Patients will be recruited from an inpatient psychiatric unit. Eligible patients who provided informed consent will be enrolled in the study that will include a eight IV ketamine treatments, 13 esketamine treatment visits, seven long assessment visits, five short assessment visits, and daily surveys. The study will examine the feasibility, tolerability, and efficacy of repeated IV ketamine followed by esketamine, as well as predictors of treatment response.

Timeline

Start
2022-10-13
Primary completion
2026-06-01
Completion
2026-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Esketamine Other / unclassified Intranasal
Subject Ketamine Small molecule Intravenous