Intranasal Ketamine In the Treatment of Pediatric Bipolar Disorder
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.
Intervention / Treatment
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Drug: Ketamine hydrochloride injection
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Drug: Flat tonic water (e.g., Canada Dry Tonic Water)
Condition or Disease
- Bipolar Disorder
Phase
Study Design
Study type: | Interventional |
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Status: | Terminated |
Study results: | No Results Available |
Age: | 6 Years to 12 Years (Child) |
Enrollment: | 5 () |
Funded by: | Other |
Masking |
Clinical Trial Dates
Start date: | Jul 12, 2020 | |
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Primary Completion: | Nov 16, 2020 | |
Completion Date: | Nov 16, 2020 | |
Study First Posted: | Jan 05, 2012 | |
Results First Posted: | Aug 31, 2020 | |
Last Updated: | Mar 16, 2017 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
Eligibility Criteria
Sex: | All |
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Minimum Age: | 6 |
Maximum Age: | 12 |
More Details
NCT Number: | NCT01504659 |
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Acronym: | IKBP |
Other IDs: | JBRF001 |
Study URL: | https://ClinicalTrials.gov/show/NCT01504659 |
Last updated: Jun 17, 2022