Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199940
Status:
COMPLETED
Last Update Posted:
2008-03-12
First Post:
2005-09-13
Brief Title:
Safety And Efficacy Study Of Ziprasidone In Pediatric Psychotic Illness
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
A Pilot Open Trial Of Ziprasidone Early In The Course Of Pediatric Psychotic Illness
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to determine if Ziprasidone is safe and effective for use in children and adolescents with a psychotic illness and to determine of Ziprasidone treatment leads to weight changes in children
Detailed Description:
Ziprasidone is a recently FDA approved antipsychotic and it holds promise in the treatment of pediatric psychosis due to its low liability for weight gain and other side effects This is important because early intervention in persons with a psychotic illness is important for their long-term treatment and outcome Unfortunately pediatric samples are often more sensitive to the side effects of psychotropic medications Because psychotropic medications are often used by clinicians long before they are studied in pediatric populations it is important to further study these agents
Twenty subjects with the diagnosis of a psychotic disorder according to DSM-IV criteria will be recruited for the study If subjects have completed baseline evaluations labs EKG and rating scales and are still eligible to participate subjects will start on 20mg of Ziprasidone at night The second week this will increase to 20 mg twice a day At visits that occur at 246and 8 weeks the subjects dose of medication can be increased in 20mg per day increments This allows for a maximum possible dose of 100mg Dosage may be decreased at any time secondary to side effects
The potential benefits are that new information will be added to the field of pediatric psychiatry and the possibility that the medication may result in improved symptoms of psychosis The potential benefits of this study outweigh the possible risks
Twenty subjects with the diagnosis of a psychotic disorder according to DSM-IV criteria will be recruited for the study If subjects have completed baseline evaluations labs EKG and rating scales and are still eligible to participate subjects will start on 20mg of Ziprasidone at night The second week this will increase to 20 mg twice a day At visits that occur at 246and 8 weeks the subjects dose of medication can be increased in 20mg per day increments This allows for a maximum possible dose of 100mg Dosage may be decreased at any time secondary to side effects
The potential benefits are that new information will be added to the field of pediatric psychiatry and the possibility that the medication may result in improved symptoms of psychosis The potential benefits of this study outweigh the possible risks
Study Oversight
Has Oversight DMC:
None
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?:
None