Valnoctamide as a valproate substitute with low teratogenic potential in mania: a double-blind, controlled, add-on clinical trial

摘要: Bersudsky Y, Applebaum J, Gaiduk Sharony L, Mishory A, Podberezsky Agam G, Belmaker RH. Valnoctamide as a valproate substitute with low teratogenic potential in mania: double-blind, controlled, add-on clinical trial. Bipolar Disord 2010: 12: 376–382. © 2010 The Authors. Journal compilation John Wiley & Sons A/S. Objectives:  Valproic acid’s well-known teratogenicity limits its use women of childbearing age. is an analog that does not undergo biotransformation to the corresponding free acid. In mice, valnoctamide has been shown be distinctly less than valproate. anticonvulsant, and we hypothesized antimanic. Methods:  We performed five-week, add-on, controlled trial mania. Patients were treated risperidone at doses physician’s discretion. or placebo was begun 600 mg/day increased 1200 mg after four days. Weekly ratings by psychiatrist blind study drug conducted using Brief Psychiatric Rating Scale (BPRS), Young Mania (YMRS), Clinical Global Impression (CGI). Results:  Fifteen patients 17 completed least one post-baseline week included data analysis. all efficacy measures more effective risperidone, two-way analysis variance (ANOVA) time within-subject factor. Two-way ANOVA showed significant effect (p < 0.001) interaction between treatment (YMRS: p = 0.012; BPRS: p = 0.007; CGI: p = 0.003). Differences from 3 5. Conclusion:  could important for age bipolar disorder who may become pregnant.