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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
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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)