Ketamine-enhanced Prolonged Exposure Therapy in PTSD
Phase II randomised, quadruple-blind parallel trial (n=75 actual) of IV ketamine (0.5 mg/kg weekly ×3) vs active placebo (midazolam 0.045 mg/kg) combined with Prolonged Exposure therapy for Veterans with PTSD.
Detailed Description
Randomised, quadruple-blind, parallel-group study evaluating IV ketamine 0.5 mg/kg given once weekly for three weeks versus midazolam active placebo, each administered 24–72 hours before Prolonged Exposure (PE) therapy sessions.
Participants are Veterans with PTSD who receive adjunctive infusions plus a course of PE (three infusion-timed PE sessions followed by seven additional PE sessions); outcomes focus on PTSD symptom change and safety/tolerability.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
Ketamine + PE
experimentalIV ketamine 0.5 mg/kg given 24–72 hrs prior to PE sessions in weeks 1–3, followed by additional PE sessions.
Interventions
- Ketamine0.5 mg/kgvia IV• weekly• 3 doses total
Infusion 24–72 hrs before PE sessions (weeks 1–3).
Midazolam + PE
activeActive placebo midazolam 0.045 mg/kg IV given 24–72 hrs prior to PE sessions in weeks 1–3, followed by additional PE sessions.
Interventions
- Placebo0.045 mg/kgvia IV• weekly• 3 doses total
Midazolam (active placebo) administered 24–72 hrs before PE sessions.
Participants
Inclusion Criteria
- male or female Veterans between the ages of 18 and 75 years
- diagnosis of PTSD
- ability to provide written informed consent
Exclusion Criteria
- females who are currently pregnant or breastfeeding
- current high risk for suicide
- history of moderate/severe head injury
- history of psychosis
- current episode of mania/hypomania
- severe substance and/or alcohol use disorder in the last 6 months