Low dose oral ketamine treatment on post-traumatic stress disorder (PTSD) (OKTOP): An open-label pilot study
Bonnie L. Quigley, Adem T. Can, Megan Dutton, Cyrana C. Gallay, Grace Forsyth, Monique Jones, Fiona Randall, Trish Wilson, Jim Lagopoulos, Daniel F. Hermens
medRxiv Preprint Server November 26, 2024 preprint DOI: 10.1101/2024.11.26.24318024 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Open-label pilot study Randomized |
|---|---|
| Sample size | 22 |
| Population | Adults aged 22-77 with PTSD, 55% female, 82% with comorbid depression |
| Intervention | Oral ketamine |
| Dose | titrated from 0.5 mg/kg to a maximum of 3.0 mg/kg |
| Duration | 6-week treatment course, 1-month follow-up |
| Topics | Ketamine Esketamine PTSD |
| Keywords | Low-dose oral ketamine PTSD Treatment PTSD Therapy PTSD Relief Symptom reduction Symptom improvement Clinical study Pilot investigation Pilot study Clinical trial Feasibility study Tolerability study |
| Citations | 1 |
| Key points | Low-dose oral ketamine administered weekly for six weeks significantly reduced PTSD symptoms, with a 73% response rate post-treatment and sustained improvement at one-month follow-up. |
Abstract
Ketamine is being actively investigated as a rapid-acting treatment for many conditions with a stress-related psychopathology, including post-traumatic stress disorder (PTSD). The majority of studies regarding ketamine treatment for PTSD to date (including open-label and randomised control trials) have focused on intravenous (IV) ketamine administration. This administration route has limitations that can be overcome with oral ketamine. As such, this study undertook the first open-label low dose Oral Ketamine Trial on PTSD (OKTOP) to determine the safety and feasibility of sub-anaesthetic ketamine for PTSD symptom reduction. Participants with PTSD (n = 22 adults, aged 22-77 years, 55% female, 82% with comorbid depression) followed a weekly treatment course of low dose oral ketamine (titrated from 0.5 mg/kg to a maximum of 3.0 mg/kg) for six weeks. The primary outcome measure was the PTSD Checklist (PCL-5), with secondary measures including scales for depression, anxiety, stress, suicidality, sleep, and wellbeing. Mean PCL-5 scores were significantly reduced from a pre-ketamine baseline score of 40 to a post-ketamine score of 17 and remained at a reduced score (21) at follow-up, 1-month post-treatment. This reduction resulted in a response rate (defined as a ≥50% reduction in PCL-5 score from baseline) of 73% post-ketamine and 59% at follow-up. This response rate is comparable with IV ketamine trials for PTSD and suggests oral ketamine administration is a feasible and tolerable treatment for PTSD.
Comparable studies
Other non-randomized and open-label trials on ketamine for PTSD, most cited first.