Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256997
Status:
TERMINATED
Last Update Posted:
2013-12-05
First Post:
2005-11-18
Brief Title:
A Study of Risperidone Long-Acting Injection Versus Oral Antipsychotics in Schizophrenia Participants With a History of Being Poorly Compliant With Taking Their Medication
Sponsor:
Janssen-Ortho Inc Canada
Organization:
Janssen-Ortho Inc Canada
Study Overview
Official Title:
Pragmatic Randomized Trial of Risperdal Consta Versus Oral Atypical Antipsychotics in Poorly Adherent Subjects With Schizophrenia in a Routine Care Setting
Status:
TERMINATED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inability to recruit number of planned patients
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 evaluate risperidone long-acting injection an antipsychotic medication versus oral antipsychotics in schizophrenia psychiatric disorder with symptoms of emotional instability detachment from reality often with delusions and hallucinations and withdrawal into the self participants with a history of being poorly compliant with taking their medication
Detailed Description:
This is a Phase 4 an open-label all people know the identity of the intervention multi-country and multi-centric conducted in more than one center study of risperidone long-acting formulation versus oral having to do with the mouth atypical antipsychotics in participants with a Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text revision DSM-IV TR diagnosis of schizophrenia currently being treated with oral antipsychotic medication The duration of this study will be 2 years All the eligible participants will be randomly assigned to an oral atypical antipsychotic risperidone olanzapine quetiapine and where commercially available aripiprazole and amisulpride or to risperidone long-acting formulation For risperidone long-acting formulation participants study medication will be administered by intramuscular into the muscle injection every 2 weeks at doses of 25 375 or 50 milligram mg Oral supplementation with the current oral atypical antipsychotic is required for the first 3 weeks following the initial injection and dose increase Dose increase can be made as per product labeling The primary measure of effectiveness is the reduction in the percentage of participants experiencing a clinical exacerbation after being in the study for 3 months Participants safety will be monitored throughout the study
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 |
|---|---|---|---|
| RISSCH4055 | None | None | None |