Intranasal Ketamine In the Treatment of Pediatric Bipolar Disorder
- Conditions
- Bipolar Disorder
- Interventions
- Drug: Flat tonic water (e.g., Canada Dry Tonic Water)
- Registration Number
- NCT01504659
- Lead Sponsor
- Juvenile Bipolar Research Foundation
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- Males and females aged 6-12;
- DSM-IV bipolar disorder (BPI, BPII, BP-NOS, BP-FOH);
- Treatment resistant - as defined by failure to adequately respond to at least 2 different classes of medications such as mood stabilizers and antipsychotic agent.
- Contraindication to the use of ketamine, including allergy and current use of medicine contraindicated with ketamine;
- Endocrine or neurological illness;
- 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;
- Previous history of glaucoma or acute globe injury
- Abnormal nasal physiology which would not allow for adequate medication delivery;
- Any change in medication type or dose within the past 30 days;
- Treatment with any MAOI's currently or within the past 3 months;
- Has had a course of ECT within the past 3 months;
- Has ever used PCP or ketamine;
- Meets DSM-IV criteria for Mental Retardation;
- Has ever had Repetitive Transcranial Magnetic Stimulation (rTMS), Vagal Nerve Stimulation (VNS) or Deep Brain Stimulation;
- Is currently hospitalized;
- Has known or suspected schizophrenia, even if currently stable or controlled with medications
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bipolar-Ketalar Ketamine hydrochloride injection Children with a diagnosis of BP-I, BP-II or BP-NOS will receive 4 administrations of intranasal ketalar Bipolar-Placebo Flat tonic water (e.g., Canada Dry Tonic Water) Children with a diagnosis of BP-I, BP-II or BP-NOS will receive 4 administrations of placebo
- Primary Outcome Measures
Name Time Method Young Mania Rating Scale Change from baseline at 17 days Overt Aggression Scale Change from baseline at day 17 Yale Brown Obsessive Compulsive Scale Change from baseline at Day 18, aggressive and obsessive questions
- Secondary Outcome Measures
Name Time Method Wechsler Intelligence Scale for Children-IV Change from baseline at day 18 SpO2 Change from baseline over 16 hours spanning days 6-7 and 15-16. 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.
Delis-Kaplin Executive Function System Change from baseline on day 18 SCARED change from baseline at day 18 body temperature Change from baseline over 16 hours spanning days 6-7 and 15-16. A proprietary ambulatory monitor will measure skin and tympanic temperature using conventional thermistors and IR sensors
Triaxial acceleration Change from baseline over 16 hours spanning days 6-7 and 15-16. 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.
Conner's Continuous Performance Test Change from baseline on day 18 Peripheral Thermal Challenge Change from baseline on days 6, 7, 15 and 16 Galvanic skin response Change from baseline over 16 hours spanning days 6-7 and 15-16. A proprietary ambulatory monitor will measure galvanic skin response obtained with two conventional electrodes.
Trial Locations
- Locations (2)
Individual homes of subjects
🇺🇸Not Predetermined, New York, United States
Juvenile Bipolar Research Foundation
🇺🇸Maplewood, New Jersey, United States