Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423878
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2007-01-16
Brief Title:
Comparison of Antipsychotics for Metabolic Problems in Schizophrenia or Schizoaffective Disorder
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institute of Mental Health NIMH
Study Overview
Official Title:
Clinical Management of Metabolic Problems in Patients With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2010-11
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:
CAMP
Brief Summary:
The study will compare the effectiveness of antipsychotic medications for patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease
Detailed Description:
Metabolic abnormalities associated with cardiovascular morbidity and premature mortality are more common in patients with schizophrenia than in matched controls Although there is some evidence that patients with schizophrenia have intrinsic abnormalities in lipid and carbohydrate metabolism some antipsychotics ie clozapine olanzapine quetiapine and risperidone are associated with increased rates of metabolic abnormalities that predispose patients to cardiovascular disease
This is an investigator-initiated clinical trial that will be conducted at 30 research sites that are a part of the NIMH Schizophrenia Trials Network
The aims of the study are to 1 determine the relative effects of switching to aripiprazole versus continued treatment with olanzapine quetiapine or risperidone on metabolic parameters associated with cardiovascular disease and 2 to determine the effects of switching to aripiprazole versus continued treatment with olanzapine quetiapine or risperidone on the clinical stability of schizophrenic illness
This study design is a multi-site single-blind rater randomized controlled trial of 300 patients with schizophrenia or schizoaffective disorder comparing treatment with the following medications olanzapine quetiapine risperidone and aripiprazole The study will enroll patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease in spite of adequate control of symptoms on their current antipsychotic medication Patients who are taking olanzapine quetiapine or risperidone and who have a body-mass index BMI greater than or equal to 27 and non-HDL cholesterol greater than or equal to 130 mgdl will be eligible if non-HDL is between 130-139mgdL LDL cholesterol must be greater than 100mgdL All treatments will be open label Raters will be blinded to treatment assignment Patients will be followed for up to 6 months
This is an investigator-initiated clinical trial that will be conducted at 30 research sites that are a part of the NIMH Schizophrenia Trials Network
The aims of the study are to 1 determine the relative effects of switching to aripiprazole versus continued treatment with olanzapine quetiapine or risperidone on metabolic parameters associated with cardiovascular disease and 2 to determine the effects of switching to aripiprazole versus continued treatment with olanzapine quetiapine or risperidone on the clinical stability of schizophrenic illness
This study design is a multi-site single-blind rater randomized controlled trial of 300 patients with schizophrenia or schizoaffective disorder comparing treatment with the following medications olanzapine quetiapine risperidone and aripiprazole The study will enroll patients with schizophrenia or schizoaffective disorder for whom a medication change may be indicated because of an increased risk of cardiovascular disease in spite of adequate control of symptoms on their current antipsychotic medication Patients who are taking olanzapine quetiapine or risperidone and who have a body-mass index BMI greater than or equal to 27 and non-HDL cholesterol greater than or equal to 130 mgdl will be eligible if non-HDL is between 130-139mgdL LDL cholesterol must be greater than 100mgdL All treatments will be open label Raters will be blinded to treatment assignment Patients will be followed for up to 6 months
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 AT-AP | OTHER | National Institute of Mental Health | None |