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A targeted treatment for children struggling with bipolar disorder.

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.

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.