Intranasal Ketamine In the Treatment of Pediatric Bipolar Disorder

Condition(s) targeted: Bipolar Disorder

Intervention: Ketamine hydrochloride injection (Drug); Flat tonic water (e.g., Canada Dry Tonic Water) (Drug)

Phase: Phase 2/Phase 3

Status: Suspended

Sponsored by: Juvenile Bipolar Research Foundation

Official(s) and/or principal investigator(s):
Demitri Papolos, MD, Principal Investigator, Affiliation: Juvenile Bipolar Research Foundation

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.

Official title: Intranasal Ketamine In the Treatment of Pediatric Bipolar Disorder

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Young Mania Rating Scale

Young Mania Rating Scale

Young Mania Rating Scale

Young Mania Rating Scale

Overt Aggression Scale

Overt Aggression Scale

Overt Aggression Scale

Overt Aggression Scale

Yale Brown Obsessive Compulsive Scale

Secondary outcome:

Wechsler Intelligence Scale for Children-IV

Peripheral Thermal Challenge

body temperature

Triaxial acceleration

SpO2

Galvanic skin response

Delis-Kaplin Executive Function System

Conner's Continuous Performance Test

SCARED

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Males and females aged 6-12; 2. DSM-IV bipolar disorder (BPI, BPII, BP-NOS, BP-FOH);

3. Treatment resistant - as defined by failure to adequately respond to at least 2

different classes of medications such as mood stabilizers and antipsychotic agent. Exclusion Criteria: 1. Contraindication to the use of ketamine, including allergy and current use of medicine contraindicated with ketamine; 2. Endocrine or neurological illness; 3. Previous history of closed head injury, current head injury associated with possible intracranial hypertension, central nervous system masses, abnormalities, or hydrocephalus, ever had loss of consciousness; 4. Previous history of glaucoma or acute globe injury 5. Abnormal nasal physiology which would not allow for adequate medication delivery; 6. Any change in medication type or dose within the past 30 days; 7. Treatment with any MAOI's currently or within the past 3 months; 8. Has had a course of ECT within the past 3 months; 9. Has ever used PCP or ketamine; 10. Meets DSM-IV criteria for Mental Retardation; 11. Has ever had Repetitive Transcranial Magnetic Stimulation (rTMS), Vagal Nerve Stimulation (VNS) or Deep Brain Stimulation; 12. Is currently hospitalized; 13. Has known or suspected schizophrenia, even if currently stable or controlled with medications 14. Is acutely suicidal or homicidal (i. e., in imminent danger with plan, urges and intent to harm oneself or others) including any serious attempts/those requiring hospitalization in the past 12 months or at the PI's discretion; 15. The presence of any abnormal laboratory findings or serious medical disorder or condition including: clinically significant organ system dysfunction; significant endocrine disease, including diabetes mellitus; hypothyroidism; cardiovascular disease (myocardial ischemia, heart failure, arrhythmias); coagulopathy; significant anemia; significant acute infection; glaucoma; dehydration; epilepsy; any intra-abdominal or intrathoracic surgery or limb amputation within the prior 6 months; any diagnosed cardiac condition causing documented hemodynamic compromise or dysfunction of the SA or AV node; any diagnosed respiratory condition causing documented or clinically recognized hypoxia (e. g., chronic obstructive or restrictive pulmonary disease); body weight approximately < 80% or > 120% ideal body weight; or any medical condition known to interfere with cognitive performance; medication-related exclusions include narcotic therapy, chronic acetaminophen use, acute sedative hypnotic withdrawal, corticosteroid or spironolactone therapy, regularly dosed narcotics or any other sedative therapy or medication that interferes with SA or AV node function or could be considered contraindicated with the sedative properties of ketamine.

Individual homes of subjects, Not Predetermined, Connecticut, United States

Juvenile Bipolar Research Foundation, Maplewood, New Jersey 07040, United States

Individual homes of subjects, Not Predetermined, New Jersey, United States

Individual homes of subjects, Not Predetermined, New York, United States

Juvenile Bipolar Research Foundation

Diagnostic Assessment Program for Juvenile Bipolar Disorder

Starting date: July 2012
Last updated: November 20, 2013