Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132314
Status:
COMPLETED
Last Update Posted:
2013-12-20
First Post:
2005-08-17
Brief Title:
Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 555 - Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
Status:
COMPLETED
Status Verified Date:
2013-10
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:
In the proposed study 450 veterans with a primary diagnosis of schizophrenia who had at least one psychiatric hospitalization for schizophrenia in the previous 2 years would be randomly assigned at 16 VA medical centers to long-acting injectable risperidone or doctors choice of oral antipsychotic medication ie excluding other long-acting injectable medications but not specifying any particular oral agents or dosages Recruitment would take 27 months to complete and the study would continue for a third year to allow 9 months of follow-up for the last patient recruited All patients would be treated from the time of entry up to the end of the three-year study period Follow-up assessments would continue quarterly Treatments would not be blinded since giving placebo injections to the comparison group would interfere with the goal of comparing the acceptability of two different methods of medication administration However end points will be blindly rated
Detailed Description:
The purpose of the study is to assess the effectiveness of long-acting injectable risperidone on psychiatric inpatient hospitalization schizophrenia symptoms quality of life medication adherence side effects and health care costs
Objectives
Primary To evaluate the impact of long-acting intramuscular IM risperidone on risk of inpatient psychiatric hospitalization in comparison to standard oral antipsychotic treatment in a randomized controlled trial to be conducted with 450 veterans diagnosed with schizophrenia or schizoaffective disorder at 16 VA medical centers over three years
Secondary To evaluate adherence health benefits and costs of long-acting IM risperidone as compared to standard oral antipsychotic treatment as measured by a symptom reduction over 12 months b time to all-cause medication discontinuation c quality of life d VA and non-VA health service use and related costs e medication side effects f violent behavior g use of concomitant medication and h the incremental cost-effectiveness ratio
Objectives
Primary To evaluate the impact of long-acting intramuscular IM risperidone on risk of inpatient psychiatric hospitalization in comparison to standard oral antipsychotic treatment in a randomized controlled trial to be conducted with 450 veterans diagnosed with schizophrenia or schizoaffective disorder at 16 VA medical centers over three years
Secondary To evaluate adherence health benefits and costs of long-acting IM risperidone as compared to standard oral antipsychotic treatment as measured by a symptom reduction over 12 months b time to all-cause medication discontinuation c quality of life d VA and non-VA health service use and related costs e medication side effects f violent behavior g use of concomitant medication and h the incremental cost-effectiveness ratio
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