drugset / Trial / NCT01504659

Intranasal Ketamine In the Treatment of Pediatric Bipolar Disorder

NCT01504659

Phase 2/3 Terminated 5 enrolled Juvenile Bipolar Research Foundation
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2012-07
Primary completion
2016-11
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ketamine Small molecule 10 mg Intranasal
Comparator Ketamine Small molecule 20 mg Intranasal

Indications