Just thought you guys might be interested - I certainly am as this is being trialed in children and adults with great results. "JBRF received approval from the U.S. Food and Drug Administration ("FDA") to begin the clinical trial of a pharmaceutical agent to treat the symptoms of bipolar disorder in children. The clinical trial will study the efficacy and safety of the use of intranasal ketamine in the treatment of children ages 6-12 with bipolar disorder and an identifiable biological marker associated with body temperature dysregulation. This FDA approval is especially noteworthy because, whereas ketamine has been studied as a treatment for depression in adults, this will be the first time ketamine will be tested as a treatment option for bipolar disorder in children. JBRF is sponsoring the first placebo-controlled study to apply this novel treatment in this age group. Another "first" of importance: clinicians will use an intranasal form of administration making this the first controlled study of ketamine using an intranasal rather than an intravenous delivery system. Clearly this is a much more child-friendly manner of medicating. JBRF Director of Research, Dr. Demitri Papolos, and his colleagues have conducted a pilot study with over 30 children who struggle with bipolar disorder and are resistant to traditional treatments. The pilot study has yielded promising results. 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 of children, termed Fear of Harm, in the Journal of Affective Disorders in 2009<http://cts.vresp.com/c/?JuvenileBipolarResea/7223905c39/64fc2383ff/05dfb5f376>. Children who have this severe type of bipolar disorder exhibit symptoms that reflect high levels of fear as well as defensive or reactive aggressive behaviors, and dramatic shifts in states of arousal: * intense fear of harm coming to self or others * territorial aggression/hoarding * particular sleep disturbances * parasomnias * overheating despite neutral temperature The children who fit this phenotype share some common traits: they have difficulty settling at night and difficulty getting to sleep once in bed, they sleep fitfully and/or awaken throughout the night, and they have difficulty arising in the morning. Further research identified a specific biological marker that is attributed to this severe subtype of the illness in children. This marker is associated with a dysregulation of body temperature. JBRF investigators will continue to study the dysregulation of body temperature on children in the intranasal ketamine trial by using a novel monitor designed to collect a wide range of physiological signals related to temperature and sleep. The treatment study is expected to last approximately 12 months. Can you imagine being able to provide a targeted and effective treatment to children with bipolar disorder?"