Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00421954
Status:
COMPLETED
Last Update Posted:
2017-01-13
First Post:
2007-01-12
Brief Title:
Open-label Ziprasidone Study for Psychosis Treatment in Adolescents
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Open-label Feasibility Study for the Treatment of Psychotic Adolescents With Ziprasidone in the Inpatient and Day Hospital Settings
Status:
COMPLETED
Status Verified Date:
2017-01
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:
This open-label study will assess the medication Geodon Ziprasidone in pediatric patients aged 13-17 diagnosed with psychotic disorder Eligible adolescents will receive Geodon for 7 weeks and stay at the NYSPI Childrens Day Unit CDU during the day If clinically appropriate they may also stay at the New York State Psychiatric Institute NYSPI Schizophrenia Research Unit SRU inpatient facility
Detailed Description:
This study is an open-label assessment of the feasibility of treating adolescents with psychotic disorders schizophreniform disorder schizoaffective disorder psychosis not otherwise specified NOS major depressive disorder with psychotic features and bipolar disorder with psychotic features in an inpatient and day hospital setting with ziprasidone Geodon Ziprasidone is a second-generation antipsychotic SGA that is FDA-approved for the treatment of schizophrenia and for the treatment of the manic phase of bipolar disorder in adults It is also used clinically in the treatment of psychotic disorders in children adolescents and adults This protocol will help to elucidate the feasibility of studying the treatment of psychotic disorders with ziprasidone in adolescents 13-17 years and help facilitate the further study of the treatment of psychosis with novel agents that have a favorable side effect and weight gain profile
The duration of the study can be up to 7 weeks Depending on the level of symptom severity patients will be managed on either the Schizophrenia Research Unit SRU GAS35 CGI-S5 or the Childrens Day Unit CDU of the NYSPI The seven weeks would encompass a 3 day period at the beginning of the study including time for screening and reviewing lab results Over a period of one to two weeks patients will be titrated up to 120 mgday 80 mg for patients under 45kg and if necessary cross tapered off of another SGA that had not been working successfully Subjects who do not respond to the medication after 1 week at the target dose will be discontinued from the study
The duration of the study can be up to 7 weeks Depending on the level of symptom severity patients will be managed on either the Schizophrenia Research Unit SRU GAS35 CGI-S5 or the Childrens Day Unit CDU of the NYSPI The seven weeks would encompass a 3 day period at the beginning of the study including time for screening and reviewing lab results Over a period of one to two weeks patients will be titrated up to 120 mgday 80 mg for patients under 45kg and if necessary cross tapered off of another SGA that had not been working successfully Subjects who do not respond to the medication after 1 week at the target dose will be discontinued from the study
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