Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000374
Status:
COMPLETED
Last Update Posted:
2012-01-13
First Post:
1999-11-02
Brief Title:
Treatment for First-Episode Schizophrenia
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Preventing Morbidity in First-Episode Schizophrenia
Status:
COMPLETED
Status Verified Date:
2012-01
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 3-year study will determine if the antipsychotic medications olanzapine Zyprexa and risperidone Risperdal can help patients with first-episode schizophrenia
Detailed Description:
The goal of the study is to prevent morbidity in first-episode schizophrenia using second-generation antipsychotic drugs olanzapine risperidone
Long-term studies of first-episode schizophrenia patients have clearly indicated excellent initial responsiveness of positive psychotic symptoms to treatment with conventional antipsychotic medications However in the years immediately following this initial good response morbidity increases Relapses often multiple ones are the rule and are usually precipitated by medication noncompliance There is some evidence that the second-generation antipsychotic drugs may have superior efficacy in terms of these outcome domains However these newer agents have been studied primarily in chronic andor treatment-resistant patient samples and there are virtually no long-term studies or studies comparing the new drugs with one another
First episode patients are randomly assigned to treatment with olanzapine or risperidone for 3 years Outcome measures for the initial episode include psychopathology positive negative and affective symptoms side effects neurocognition executive function memory and attention social and occupational function and service utilization The effects on long-term course are measured in terms of frequency and timing of relapses level of recovery from subsequent episodes and prospectively assessed course of psychopathology neurocognitive function socialvocational function and service utilization
For information on a related study please follow this link
httpclinicaltrialsgovshowNCT00320671
Long-term studies of first-episode schizophrenia patients have clearly indicated excellent initial responsiveness of positive psychotic symptoms to treatment with conventional antipsychotic medications However in the years immediately following this initial good response morbidity increases Relapses often multiple ones are the rule and are usually precipitated by medication noncompliance There is some evidence that the second-generation antipsychotic drugs may have superior efficacy in terms of these outcome domains However these newer agents have been studied primarily in chronic andor treatment-resistant patient samples and there are virtually no long-term studies or studies comparing the new drugs with one another
First episode patients are randomly assigned to treatment with olanzapine or risperidone for 3 years Outcome measures for the initial episode include psychopathology positive negative and affective symptoms side effects neurocognition executive function memory and attention social and occupational function and service utilization The effects on long-term course are measured in terms of frequency and timing of relapses level of recovery from subsequent episodes and prospectively assessed course of psychopathology neurocognitive function socialvocational function and service utilization
For information on a related study please follow this link
httpclinicaltrialsgovshowNCT00320671
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 |
|---|---|---|---|
| DSIR 83-ATAP | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH060004-01 |
| R01MH060004-01 | NIH | None | None |