Effect of ganaxolone in patients with posttraumatic stress disorder

Psychopharmacology, Apr 2018

Tomoyuki Kawada

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Effect of ganaxolone in patients with posttraumatic stress disorder

Effect of ganaxolone in patients with posttraumatic stress disorder Tomoyuki Kawada 0 0 Department of Hygiene and Public Health, Nippon Medical School , 1-1-5 Sendagi, Bunkyo-Ku, Tokyo 113-8602 , Japan 1 Tomoyuki Kawada - Dear Editor; Rasmusson et al. (2017a) reported a negative data concerning the effect of ganaxolone (a synthetic 3β-methylated derivative of allopregnanolone) in patients with posttraumatic stress disorder (PTSD). Ganaxolone is a GABAergic neuroactive steroid, and there were no significant differences of Clinician-Administered PTSD Symptom (CAPS) scores, global well-being, negative mood, or sleep between ganaxolone and placebo groups by intent-to-treat repeated measure analysis. The authors speculated that under-dosing would have contributed to no significance for the effect of ganaxolone in patients with PTSD. I have some concerns about their study. First, the same authors recommended clinical studies to investigate the effect of neuroactive steroid therapy in patients with PTSD by considering effective dosing regimens and by identifying neuroactive steroid system abnormalities (Rasmusson et al. 2017b). Although the authors conducted an appropriate power analysis for a randomized controlled trial, statistical procedure in sensitivity analysis might be reconsidered for keeping enough statistical power. In addition, the authors discussed of keeping plasma level of ganaxolone ≥ 20 ng/ml. Appropriate dosing of ganaxolone should also be considered by keeping safety, and continuous survey is needed. Second, the authors selected 80% of males in their trial. The same study group reported a negative relationship between serum (plasma) allopregnanolone and affective symptoms such as depression and anxiety in women by considering body mass index (Dichtel et al. 2017). I Compliance with ethical standards (...truncated)


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Tomoyuki Kawada. Effect of ganaxolone in patients with posttraumatic stress disorder, Psychopharmacology, 2018, pp. 1, DOI: 10.1007/s00213-018-4892-x