Skip to content
TerminatedPhase 2 / Phase 3

Intranasal Ketamine In the Treatment of Pediatric Bipolar Disorder

NCT01504659 · IKBP · Juvenile Bipolar Research Foundation

Closed to entry
Status
Not accepting participants
Phase 2 / Phase 3
Phase
5
Target enrolment
4
Study sites
3 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Young Mania Rating Scale

    Measured over Change from baseline at 8 days

  • Young Mania Rating Scale

    Measured over Change from baseline at 11 days

  • Young Mania Rating Scale

    Measured over Change from baseline at 14 days

  • Young Mania Rating Scale

    Measured over Change from baseline at 17 days

  • Overt Aggression Scale

    Measured over Change from baseline at day 8

  • Overt Aggression Scale

    Measured over Change from baseline at day 11

  • Overt Aggression Scale

    Measured over Change from baseline at day 14

  • Overt Aggression Scale

    Measured over Change from baseline at day 17

  • Yale Brown Obsessive Compulsive Scale

    Measured over Change from baseline at Day 18, aggressive and obsessive questions

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

6 Years to 12 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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.

Where

4 study sites

FacilityCityRegionCountry
Individual homes of subjectsNot PredeterminedConnecticutUnited States
Juvenile Bipolar Research FoundationMaplewoodNew JerseyUnited States
Individual homes of subjectsNot PredeterminedNew JerseyUnited States
Individual homes of subjectsNot PredeterminedNew YorkUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT01504659 on ClinicalTrials.gov →

Last updated in the registry 2017-03-16. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits