drugset / Trial / NCT04613453
Reducing Adolescent Suicide Risk: Safety, Efficacy, and Connectome Phenotypes of Intravenous Ketamine
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine if intravenous ketamine reduces suicidal thinking compared to an active placebo (midazolam) in adolescents who have treatment resistant depression and a recent history of a suicide event (defined as a suicide attempt, emergency room evaluation for suicidal thinking, or a transition to inpatient care for suicidality in the past 120 days). The primary objective of this study is to determine whether ketamine reduces suicidal ideation (as measured via the C-SSRS, recent ideation scale) relative to an active control, midazolam, 48-hours after first administration in adolescents with TRD at high suicide risk.
Timeline
- Start
- 2022-01-21
- Primary completion
- 2024-07-31
- Completion
- 2024-12-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ketamine | Small molecule | 0.5 mg/kg | Intravenous |
| Comparator | Midazolam | Small molecule | 0.045 mg/kg | — |
Indications
No indication recorded.