Intranasal Ketamine In the Treatment of Pediatric Bipolar Disorder

The investigators plan to evaluate the efficacy and safety of intranasal Ketalar (ketamine hydrochloride) in the treatment of primary symptom manifestations of pediatric bipolar disorder; Fear of Harm (FOH) phenotype. This phenotype represents those children who are most resistant to traditional treatments and suffer repeated hospitalizations. Primary symptoms include fearfulness, aggression secondary to threat, mood and/or arousal instability, and psychosis.

In addition to evaluation of efficacy and safety, the investigators will also analyze whether therapeutic response depends upon the degree to which the subject fits the FOH phenotype.

Topic Bipolar Disorder Depression
Compound Placebo Ketamine
Country United States of America
Visit trial
Status Terminated
Results Published No
Start date 07 January 2012
End date 11 January 2016
Phase Phase II Phase III
Design Blinded
Type Interventional
Participants 5
Sex All
Age 6- 12
Therapy No

Trial Details

The investigators plan to evaluate the efficacy and safety of intranasal Ketalar (ketamine hydrochloride) in the treatment of primary symptom manifestations of pediatric bipolar disorder; Fear of Harm (FOH) phenotype. This phenotype represents those children who are most resistant to traditional treatments and suffer repeated hospitalizations. Primary symptoms include fearfulness, aggression secondary to threat, mood and/or arousal instability, and psychosis. In addition to evaluation of efficacy and safety, the investigators will also analyze whether therapeutic response depends upon the degree to which the subject fits the FOH phenotype.

Trial Number NCT01504659

Sponsors & Collaborators

Juvenile Bipolar Research Foundation
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Data attribution

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