A randomized controlled trial of ganaxolone in posttraumatic stress disorder View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-08

AUTHORS

Ann M. Rasmusson, Christine E. Marx, Sonia Jain, Gail M. Farfel, Julia Tsai, Xiaoying Sun, Thomas D. Geracioti, Mark B. Hamner, James Lohr, Richard Rosse, Lanier Summerall, Jennifer C. Naylor, Cristine Cusin, Ariel J. Lang, Rema Raman, Murray B. Stein

ABSTRACT

Preclinical and clinical research supports a role for neuroactive steroids in the pathophysiology of posttraumatic stress disorder (PTSD). We investigated ganaxolone (a synthetic 3β-methylated derivative of allopregnanolone, a GABAergic neuroactive steroid) for treatment of PTSD in a proof-of-concept, multisite, double-blind, placebo-controlled trial. Veteran and non-veteran participants (n = 112) were randomized to ganaxolone or placebo at biweekly escalating doses of 200, 400, and 600 mg twice daily for 6 weeks. During an open-label 6-week extension phase, the initial ganaxolone group continued ganaxolone, while the placebo group crossed over to ganaxolone. Eighty-six and 59 participants, respectively, completed the placebo-controlled and open-label phases. A modified intent-to-treat mixed model repeated measures analysis revealed no significant differences between the effects of ganaxolone and placebo on Clinician Administered PTSD Symptom (CAPS) scores, global well-being, negative mood, or sleep. Dropout rates did not differ between groups, and ganaxolone was generally well tolerated. Trough blood levels of ganaxolone at the end of the double-blind phase were, however, lower than the anticipated therapeutic level of ganaxolone in >35% of participants on active drug. Pharmacokinetic profiling of the ganaxolone dose regimen used in the trial and adverse event sensitivity analyses suggest that under-dosing may have contributed to the failure of ganaxolone to out-perform placebo. Future investigations of ganaxolone may benefit from higher dosing, rigorous monitoring of dosing adherence, a longer length of placebo-controlled testing, and targeting of treatment to PTSD subpopulations with demonstrably dysregulated pre-treatment neuroactive steroid levels. Clinicaltrials.gov identifier: NCT01339689. More... »

PAGES

2245-2257

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00213-017-4649-y

DOI

http://dx.doi.org/10.1007/s00213-017-4649-y

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1090313932

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28667510


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