Ketamine and Mindfulness Based Cognitive Therapy (MBCT) in Treatment of Post-Traumatic Stress Disorder (PTSD): Comparison of Treatment Efficacy and Metabolomic Profiles

Randomized, placebo-controlled, crossover pilot (Cooper University Hospital, Camden NJ; sponsor: The Cooper Health System; PI: Basant Pradhan, MD) comparing a single IV infusion of ketamine 0.5 mg/kg (over 40 minutes) versus normal saline placebo, each delivered on top of a standardized TIMBER (Trauma Interventions using Mindfulness Based Extinction and Re-consolidation of trauma memories) psychotherapy protocol, in adults aged 21–60 with chronic DSM-IV PTSD (PCL-C ≥51, CAPS ≥50 on the first 17 items). Two arms: TIMBER-Ketamine (experimental) and TIMBER-placebo (placebo comparator), quadruple-masked (participant, care provider, investigator, outcomes assessor). Primary outcomes: change in Clinician-Administered PTSD Scale (CAPS) and PTSD Checklist (PCL) at 25 hours post-infusion. Secondary outcomes: Hamilton Depression Rating Scale (17-item) and Beck Anxiety Scale at 25 hours. Target enrollment: 50. Study start August 2013; primary completion December 2017 (estimated). Overall status listed as Unknown on ClinicalTrials.gov.