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.
Study Arms & Interventions
TIMBER-K
experimentalKetamine infusion combined with 12 TIMBER psychotherapy sessions.
Interventions
- Ketamine0.5 mg/kgvia IV• single dose• 1 doses total
(R,S)-ketamine infusion; combined with 12 TIMBER sessions (3 in first week, then weekly)
TIMBER-P
placeboPlacebo (normal saline) infusion combined with 12 TIMBER psychotherapy sessions.
Interventions
- Placebo nullvia IV• single dose• 1 doses total
Normal saline infusion; combined with 12 TIMBER sessions
TIMBER-K (Crossover)
experimentalPatients from the TIMBER-P group switched to ketamine infusion and TIMBER sessions after sustained relapse.
Interventions
- Ketamine0.5 mg/kgvia IV• single dose• 1 doses total
Crossover arm for patients experiencing sustained relapse
Primary Results(1 publication)
Participants
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| TIMBER-Kexperimental | 5 | — | 0(0.0%) | 0(0.0%) | 0(0.0%) |
| TIMBER-Pplacebo | 5 | — | 0(0.0%) | 0(0.0%) | 0(0.0%) |
| TIMBER-K (Crossover)experimental | 5 | — | 0(0.0%) | 0(0.0%) | 0(0.0%) |
* No clinically significant side effects, severe AEs, serious AEs, discontinuations due to AEs, or suicidal behavior were observed during the 18-month follow-up period. Two subjects experienced mild nausea within 1-hour post-infusion (pooled data, not specified per arm).
* No clinically significant side effects, severe AEs, serious AEs, discontinuations due to AEs, or suicidal behavior were observed during the 18-month follow-up period, which includes the crossover period. No specific adverse events were reported for the crossover phase.