Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222495
Status:
COMPLETED
Last Update Posted:
2006-09-11
First Post:
2005-09-16
Brief Title:
A Comparative Study of New Medications for Psychosis in Adolescents
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
A Comparative Study of New Medications for Psychosis in Adolescents
Status:
COMPLETED
Status Verified Date:
2006-09
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 overall goal of this study is to determine the efficacy and tolerability of three atypical antipsychotic medications risperidone olanzapine and quetiapine in the treatment of adolescents with psychosis It is hypothesized that the three medications will be equally effective in reducing the symptoms of psychosis
Detailed Description:
The purpose of this study is to compare the efficacy and tolerance of three atypical antipsychotics which are medications that have been in use for about the last 10 years in the treatment of psychosis in adolescents Efficacy refers to how well the medications work in decreasing symptoms associated with schizophrenia and tolerance refers to the level of side effects and the compliance with taking the medications All three medications have demonstrated efficacy in treating psychosis without causing extra pyramidal side effects uncontrolled muscle movements that are associated with typical or older antipsychotic medications Young people may be at a greater risk for side effects from the typical antipsychotic medications There are studies of the efficacy and tolerance among patients under 18-years-old taking the three drugs in this study risperidone olanzapine and quetiapine However at this time there is little data available comparing these three medications This study is an open-label random assignment 12-week study to assess the efficacy and tolerance of these three atypical antipsychotic medications in the treatment of adolescents ages 12-18 with schizophrenia or psychosis The participants will be informed of which medication shehe is taking and will be assigned to the medication randomly based on chance rather than choice
There are additional theoretical beliefs in regard to this study as well A secondary hypothesis of this study is that quetiapine will have less extra pyramidal side effects EPS and less prolactin-related side effects than risperidone A third hypothesis is that quetiapine will lead to less weight gain than olanzapine and risperidone Finally it is hypothesized that because of the fewer side effects quetiapine will be better tolerated than risperidone and olanzapine
There are additional theoretical beliefs in regard to this study as well A secondary hypothesis of this study is that quetiapine will have less extra pyramidal side effects EPS and less prolactin-related side effects than risperidone A third hypothesis is that quetiapine will lead to less weight gain than olanzapine and risperidone Finally it is hypothesized that because of the fewer side effects quetiapine will be better tolerated than risperidone and olanzapine
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