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

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.

NCT Number	NCT05450432
Lead Sponsor	Massachusetts General Hospital Collaborators: American Foundation for Suicide Prevention
Conditions	Major Depressive Disorder
Enrollment	100 participants
Start Date	2022-10-13
Primary Completion	2026-06-01 (estimated)
Study Completion	2026-06-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-12