The criteria established for enrollment is the combination of both inclusionary and exclusionary criteria.
- The child must be between the ages of 6 and 12. While children younger than 6 have been treated during the pilot study, it was seen as a reasonable minimum age for compliance with study requirements.
- The child must qualify for a diagnosis of bipolar I, II or NOS.
- The child must be treatment resistant – as defined by failure to adequately respond to at least 2 different classes of medications such as mood stabilizers and antipsychotic agent.
- Practical criteria for the efficient execution of the study include:
- Child must reside within 50 miles of New York City and Westport, CT. (additional geographical hubs may be included as the study progresses.)
- Location where child resides must have access to broadband or high speed internet.
Ketamine is frequently used for children in the Emergency Room. For that purpose, a set of guidelines is used to determine when ketamine should NOT be used. We have adopted this set of criteria (except for those criteria unique to surgery) even though the use of ketamine in this study will not reach the degree of sedation effect when it is used in the Emergency Room. We felt this would provide a wide margin of safety.
Those criteria are:
- 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
- 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 that may, in the judgment of the PI, confound the assessment of relevant biologic measures or diagnoses 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; fever; 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, in the PI’s judgment, interferes with SA or AV node function or could be considered contraindicated with the sedative properties of ketamine.
- Abnormal nasal physiology which would not allow for adequate medication delivery.