A randomized, double-blind, clinical pilot trial of adjunct ketone supplement compared to placebo for treating posttraumatic stress disorder.

BACKGROUND: Despite some evidence of the helpful role of ketones in some neuropsychiatric disorders, there are no clinical trials that examine these agents for posttraumatic stress disorder (PTSD). Our aim was to investigate whether ketone salt supplementation can improve PTSD symptoms in a randomized, placebo-controlled trial. METHODS: A total of 21 participants were recruited and randomized to placebo or ketone supplement. Each dose of ketone supplement included 7 g of ketones in the form of beta-hydroxybutyrate for a total of 14 g/d. Data were collected through questionnaires to assess PTSD symptoms. We used Fisher's exact tests for categorical variables and 2-sample t tests for continuous variables to examine differences in baseline values between treatment groups. Mixed models were employed to examine changes over time between groups on the PTSD Checklist for DSM-5 (PCL-5). RESULTS: There were no statistically significant differences in PCL-5 medians between the ketone and control groups at pretest (P = 1.0000) or post-test (P = .6020). The ketone group had a statistically significant decrease in median PCL-5 scores from 58.5 (pretest) to 54.0 (posttest; P = .0003) but the control group did not change (34 at pretest and at posttest; P = .4418). CONCLUSIONS: The ketone group showed a significant decrease in PCL-5 score at posttest compared with pretest that was not seen in the control group, although these changes were not statistically significant between groups. The small sample size limited the study and likely contributed to the lack of significance. Larger trials are needed to more definitively examine these findings.

Examining the characteristics of patients who continue participation in vs those who drop out of a PTSD clinical trial

BACKGROUND: Patients who drop out of clinical trials examining posttraumatic stress disorder (PTSD) may have different characteristics than patients who continue. These characteristics have never been examined in prior PTSD and attrition trials. Our goal was to examine how demographic and clinical characteristics of patients with PTSD impact attrition in a randomized controlled trial. METHODS: A total of 18 participants were recruited. Data were collected through questionnaires to assess PTSD, depression, and mood disorders. Fisher's exact test was used to examine the association of various categorical demographic and clinical variables with dropout. A Wilcoxon rank sum test was used to examine differences in medians. RESULTS: The median total PTSD Checklist for DSM-5 score was 38 for patients who dropped out and 53 for those who did not. The depression scale total was also lower for the dropout group (7 vs 15). The insomnia index was lower for those who did not remain in the study (15 vs 21). CONCLUSIONS: Posttraumatic stress disorder symptoms, depression, and insomnia were less severe in patients who dropped out compared with those who did not. Larger studies are needed to further examine these findings. This study could help guide future recruitment efforts for clinical trials examining PTSD.