drugset / Trial / NCT05450432
Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression
Phase 4
Recruiting
100 enrolled
Massachusetts General Hospital
American Foundation for Suicide Prevention · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esketamine | Other / unclassified | — | Intranasal |
| Subject | Ketamine | Small molecule | — | Intravenous |