Parallel Phase II study (n=247) comparing neural-exosomal miRNAs in three MDD groups (recent attempt, suicidal ideation, no ideation) given a single IV ketamine infusion (0.5 mg/kg) and healthy controls with one-time blood draw.
Parallel-group study enrolling MDD participants with recent suicide attempt, MDD with serious suicidal ideation, MDD without significant ideation, and healthy controls; MDD groups receive a single IV ketamine infusion (0.5 mg/kg over 40 minutes).
Blood samples for neural-derived exosomal miRNA analysis are collected pre-infusion, 30 minutes, 180 minutes, 24 hours and 14 days post-infusion; healthy controls provide a single blood draw. The aim is to identify miRNA signatures associated with suicidality and ketamine treatment response.
Data collection is complete as of July 2022 and analysis was ongoing as of May–July 2022; final outcomes will be reported upon completion of analyses.
MDD participants with a suicide attempt in past 2 weeks receiving single IV ketamine infusion.
Infusion 0.5 mg/kg delivered over 40 minutes (rate ~40 mL over 40 min). Blood at pre, 30 min, 180 min, 24 h, 14 days.
MDD participants with serious ideation (past 7 days) without recent attempt receiving single IV ketamine infusion.
Infusion 0.5 mg/kg over 40 minutes; blood draws at pre, 30 min, 180 min, 24 h, 14 days.
MDD participants without recent ideation or attempt receiving single IV ketamine infusion.
Infusion 0.5 mg/kg over 40 minutes; blood draws at pre, 30 min, 180 min, 24 h, 14 days.
Healthy control participants with one-time blood draw; no ketamine.
One-time blood draw; no ketamine.