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

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

Condition or Disease

  • Bipolar Disorder

Phase

Study Design

Study type: Interventional
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
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

Eligibility Criteria

Sex: All
Minimum Age: 6
Maximum Age: 12

More Details

NCT Number: NCT01504659
Acronym: IKBP
Other IDs: JBRF001
Study URL: https://ClinicalTrials.gov/show/NCT01504659
Last updated: Jun 17, 2022