Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2025-12-26 @ 11:04 PM
Study NCT ID:
NCT01504659
Status:
TERMINATED
Last Update Posted:
2017-03-16
First Post:
2012-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intranasal Ketamine In the Treatment of Pediatric Bipolar Disorder
Sponsor:
Juvenile Bipolar Research Foundation
Organization:
Study Overview
Official Title:
Intranasal Ketamine In the Treatment of Pediatric Bipolar Disorder
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administrative issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IKBP
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: