FDA

Maplewood, NJ – November 3, 2011The Juvenile Bipolar Research Foundation (“JBRF”) announced today that the Federal Drug Administration (“FDA”) has approved its submission of a request to study the use of intranasal ketamine in the treatment of children ages 6-12 with bipolar disorder who also have an identifiable biological marker associated with body temperature dysregulation. “This research, funded by donations from supporters of JBRF, will be the first placebo-controlled study to apply this novel treatment in this age group “ said Inger Sjogren, Executive Director of the JBRF.Dr. Demitri Papolos, Director of Research of the JBRF, noted that a controlled study of ketamine using, for the first time, an intranasal form of administration will build upon previous work performed in both children and adults. A pilot study that he and his colleagues have conducted with over 30 children who struggle with bipolar disorder and are resistant to traditional treatments has already shown great promise using this approach. In many cases, full resolution of symptoms in the most severe form of the disorder has been observed. This work is consistent with findings from studies in adults with treatment resistant depression who received a single dose of ketamine given intravenously.Ketamine may prove to have the most positive impact on a unique set of behavioral, cognitive and physiological characteristics associated with a group of children who are the most resistant to traditional treatments and suffer repeated hospitalizations.  Dr. Papolos and his colleagues first reported on the specific behavioral attributes in this group, termed Fear of Harm, in the Journal of Affective Disorders in 2009. Since that time, a specific biological marker has been attributed to this severe subtype of the illness in children. This marker, associated with a dysregulation of body temperature will be further studied with the use of a novel monitor designed to collect a wide range of physiological signals related to temperature and sleep.Ms. Sjogren said that the study was expected to begin within the next 3 months and last approximately 12 months. Further information is available at http://www.jbrf.org.The JBRF is a 501(c)(3) corporation founded to support research into the study and treatment of bipolar disorder in children and adolescents.

For information regarding the JBRF and its mission please contact Executive Director Inger Sjogren at ingersjogren@jbrf.org.