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

This interventional trial (n=100) aims to investigate the long-term maintenance effects of ketamine and esketamine on reducing suicide risk in patients with Major Depressive Disorder (MDD) and suicidal ideation (SI).

Conducted by Massachusetts General Hospital, the study involves patients recruited from an inpatient psychiatric unit. Participants will receive eight intravenous ketamine treatments followed by 13 intranasal esketamine treatments, with additional assessment and daily surveys.

The primary purpose is treatment, with a phase IV design and a single-group assignment. The study will assess feasibility, tolerability, and efficacy of the treatment regimen, including predictors of treatment response.

Key outcome measures include feasibility indicators such as retention and drop-out rates, as well as tolerability measures including cognitive function, side effects, and adjustments in dosage and frequency of treatment. Secondary outcome measures include treatment response, changes in suicidal ideation and depression, hospital readmission rates, prevalence of suicidal behavior, and healthcare utilization rates. The study commenced in October 2022 and is estimated to conclude in June 2025.

Trial Details

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.

Trial Number NCT05450432

Data attribution

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