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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
5
Separate dosing regimens will be applied depending on the weight of the child. Group A with minimum-maximum weight of 20 kg-40 kg will receive a fixed initial dose of 10 mg ketamine(0.25-0.5mg/kg)and will not exceed a maximum dose of 40 mg ketamine. Group B with minimum - maximum weight of 40.01kg-100kg will get a fixed initial dose of 20 mg ketamine(0.20-0.5mg/kg) and will not exceed a maximum dose of 120mg. ketamine. There will be 4 administrations of the drug at three day intervals. Titration upward will depend upon degree of side effects, improvement from baseline on primary measures, subjective opinion. Doses will be held constant as long as a therapuetic response, as measure of 80% improvement on YBOCS and YMRS, is reached.
Separate dosing regimens will be applied depending on the weight of the child. Group A with minimum-maximum weight of 20 kg-40 kg will receive a fixed initial dose of 0.1cc placebo and not exceed a maximum dose of 0.4cc placebo. Group B with minimum - maximum weight of 40.01kg-100kg will get a fixed initial dose of 0.2cc placebo and will not exceed a maximum dose of 1.2cc. placebo. There will be 4 administrations of the placebo at three day intervals. Titration upward will depend upon degree of side effects, improvement from baseline on primary measures, and subjective opinion. Doses will be held constant as long as a therapuetic response, as a measure of 80% improvement on YBOCS and YMRS, is reached.
Individual homes of subjects
Not Predetermined, Connecticut, United States
Juvenile Bipolar Research Foundation
Maplewood, New Jersey, United States
Individual homes of subjects
Not Predetermined, New Jersey, United States
Individual homes of subjects
Not Predetermined, New York, United States
Young Mania Rating Scale
Time frame: Change from baseline at 8 days
Young Mania Rating Scale
Time frame: Change from baseline at 11 days
Young Mania Rating Scale
Time frame: Change from baseline at 14 days
Young Mania Rating Scale
Time frame: Change from baseline at 17 days
Overt Aggression Scale
Time frame: Change from baseline at day 8
Overt Aggression Scale
Time frame: Change from baseline at day 11
Overt Aggression Scale
Time frame: Change from baseline at day 14
Overt Aggression Scale
Time frame: Change from baseline at day 17
Yale Brown Obsessive Compulsive Scale
Time frame: Change from baseline at Day 18, aggressive and obsessive questions
Wechsler Intelligence Scale for Children-IV
Time frame: Change from baseline at day 18
Peripheral Thermal Challenge
Time frame: Change from baseline on days 6, 7, 15 and 16
body temperature
A proprietary ambulatory monitor will measure skin and tympanic temperature using conventional thermistors and IR sensors
Time frame: Change from baseline over 16 hours spanning days 6-7 and 15-16.
Triaxial acceleration
A proprietary ambulatory monitor will measure triaxial acceleration from the forehead using a commercially-available sensor that also provides a plethysmograph signal from which heart rate can be derived.
Time frame: Change from baseline over 16 hours spanning days 6-7 and 15-16.
SpO2
A proprietary ambulatory monitor will measure triaxial acceleration from the forehead using a commercially-available sensor that also provides a plethysmograph signal from which heart rate can be derived.
Time frame: Change from baseline over 16 hours spanning days 6-7 and 15-16.
Galvanic skin response
A proprietary ambulatory monitor will measure galvanic skin response obtained with two conventional electrodes.
Time frame: Change from baseline over 16 hours spanning days 6-7 and 15-16.
Delis-Kaplin Executive Function System
Time frame: Change from baseline on day 18
Conner's Continuous Performance Test
Time frame: Change from baseline on day 18
SCARED
Time frame: change from baseline at day 18
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