Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048828
Status:
COMPLETED
Last Update Posted:
2013-07-02
First Post:
2002-11-08
Brief Title:
Treating Drug-Resistant Childhood Schizophrenia
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Treating Refractory Childhood Schizophrenia
Status:
COMPLETED
Status Verified Date:
2013-07
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 study will compare clozapine and olanzapine Zyprexa for the treatment of children and adolescents who have failed standard antipsychotic treatment for schizophrenia
Detailed Description:
Schizophrenia is a devastating illness regardless of the age at which it presents When this disorder occurs in childhood or adolescence the consequences in terms of functional impairment loss of developmental opportunities and family and societal burden are particularly dramatic
Evidence supports the improved efficacy andor side effect profile of atypical antipsychotic medication in adults Thus it is essential to examine whether the potential benefits of these agents can be extended to children particularly children who have failed standard treatment
Patients are randomly assigned to receive either clozapine or olanzapine daily for 12 weeks Patients meet with the study team once a week to discuss progress and record side effects Three parent meetings take place during the study During these meetings questions are discussed and support and education about schizophrenia are given to parents Various scales to measure psychotic manic aggressive and depressive symptoms are used to assess patients
Evidence supports the improved efficacy andor side effect profile of atypical antipsychotic medication in adults Thus it is essential to examine whether the potential benefits of these agents can be extended to children particularly children who have failed standard treatment
Patients are randomly assigned to receive either clozapine or olanzapine daily for 12 weeks Patients meet with the study team once a week to discuss progress and record side effects Three parent meetings take place during the study During these meetings questions are discussed and support and education about schizophrenia are given to parents Various scales to measure psychotic manic aggressive and depressive symptoms are used to assess patients
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01MH060229 | NIH | None | None |
| DSIR 84-CTM | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH060229 |