Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001656
Status:
COMPLETED
Last Update Posted:
2011-04-12
First Post:
1999-11-03
Brief Title:
Comparison of Clozapine vs Olanzapine in Childhood-Onset Psychotic Disorders
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Childhood Onset Psychotic Disorders Characterization and Treatment With Atypical Neuroleptics
Status:
COMPLETED
Status Verified Date:
2011-03
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 study is to compare the effectiveness and side effects of the drugs clozapine and olanzapine in children and adolescents with schizophrenia and psychoses
Childhood psychosis is a serious disorder that may have devastating consequences Effective treatments for the condition are under continual investigation This study will examine the causes of and offer treatment for childhood psychosis
Participants in this study will undergo psychological tests blood and urine tests electroencephalogram EEG electrocardiogram EKG and magnetic resonance imaging MRI scans of the brain for the first 1 to 2 weeks of the study while taking their regular medications Participants will then be tapered off their medications over 1 to 3 weeks and will continue to stay off medications for an additional 2 days to 3 weeks During this time participants will undergo psychiatric neurological and cardiac examinations as well as blood tests After this period without medications participants will be randomly assigned to receive either clozapine or olanzapine for 8 weeks An EEG will be performed prior to treatment and after 6 weeks of study medication Participants who respond well to the study drugs may continue to receive them through their own physician Participants who do not respond to either clozapine or olanzapine or cannot tolerate their side effects will be treated individually with other drugs until optimum treatment is identified Regular telephone updates and in person visits to NIH for repeat testing and MRIs will be conducted
Childhood psychosis is a serious disorder that may have devastating consequences Effective treatments for the condition are under continual investigation This study will examine the causes of and offer treatment for childhood psychosis
Participants in this study will undergo psychological tests blood and urine tests electroencephalogram EEG electrocardiogram EKG and magnetic resonance imaging MRI scans of the brain for the first 1 to 2 weeks of the study while taking their regular medications Participants will then be tapered off their medications over 1 to 3 weeks and will continue to stay off medications for an additional 2 days to 3 weeks During this time participants will undergo psychiatric neurological and cardiac examinations as well as blood tests After this period without medications participants will be randomly assigned to receive either clozapine or olanzapine for 8 weeks An EEG will be performed prior to treatment and after 6 weeks of study medication Participants who respond well to the study drugs may continue to receive them through their own physician Participants who do not respond to either clozapine or olanzapine or cannot tolerate their side effects will be treated individually with other drugs until optimum treatment is identified Regular telephone updates and in person visits to NIH for repeat testing and MRIs will be conducted
Detailed Description:
The purpose of this protocol is to compare efficacy of clozapine and olanzapine in children and adolescents with schizophrenia and psychoses as well as to learn about side effects of these medication in pediatric population The underlying hypothesis is that clozapine has superior efficacy over olanzapine
Children and adolescents ages 7 to 18 years meeting DSM-IV criteria for schizophrenia schizoaffective disorder and psychotic disorder not otherwise specified with onset of psychosis before their 13th birthday who have not responded to at least two prior trials with typical or a typical neuroleptics will be eligible to participate in a double-blind parallel group trial of olanzapine-clozapine
This study will be done in conjunction with the Screening protocol which will include characterization by clinical phenomenology eye tracking MRI brain imaging plasma biochemistry and chromosomal analysis
This study will consist of the following phases 1 Tapering of psychotropic medications 1-4 weeks depending upon type and dosage 2 Observation for up to 2 weeks drug free in order to establish a baseline prior to starting medication trial 3 An 8 week double-blind trial of either clozapine or olanzapine Efficacy and tolerability of clozapine and olanzapine will be compared using specified criteria 4 If desired improvement not achieved or trial is interrupted an 8 week open trial of the second medication and 5 Discharge following medication optimization for up to 4 weeks or as clinically appropriate This protocol also includes a follow-up every 2 to 3 years for a period of 10 years
Children and adolescents ages 7 to 18 years meeting DSM-IV criteria for schizophrenia schizoaffective disorder and psychotic disorder not otherwise specified with onset of psychosis before their 13th birthday who have not responded to at least two prior trials with typical or a typical neuroleptics will be eligible to participate in a double-blind parallel group trial of olanzapine-clozapine
This study will be done in conjunction with the Screening protocol which will include characterization by clinical phenomenology eye tracking MRI brain imaging plasma biochemistry and chromosomal analysis
This study will consist of the following phases 1 Tapering of psychotropic medications 1-4 weeks depending upon type and dosage 2 Observation for up to 2 weeks drug free in order to establish a baseline prior to starting medication trial 3 An 8 week double-blind trial of either clozapine or olanzapine Efficacy and tolerability of clozapine and olanzapine will be compared using specified criteria 4 If desired improvement not achieved or trial is interrupted an 8 week open trial of the second medication and 5 Discharge following medication optimization for up to 4 weeks or as clinically appropriate This protocol also includes a follow-up every 2 to 3 years for a period of 10 years
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 |
|---|---|---|---|
| 97-M-0126 | None | None | None |