Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216580
Status:
COMPLETED
Last Update Posted:
2013-03-25
First Post:
2005-09-13
Brief Title:
A Pilot Study of the Use of Risperidone Long Acting Injectable in the Treatment of Patients With Recent Onset Psychosis
Sponsor:
Janssen Pharmaceutica NV Belgium
Organization:
Janssen Pharmaceutica NV Belgium
Study Overview
Official Title:
An Open-label Trial of Risperidone Long-acting Injectable in the Treatment of Subjects With Recent Onset Psychosis
Status:
COMPLETED
Status Verified Date:
2013-03
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 purpose of the study is to assess the effectiveness and safety of long-acting injectable risperidone in the treatment of patients in the early stage of psychosis
Detailed Description:
Although many schizophrenia patients currently take oral antipsychotic medications it is estimated that up to 75 of them have difficulty adhering to the daily oral regimen Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen This study is a pilot project to demonstrate that long-acting risperidone can be used safely and effectively in treating patients in the early stage of psychosis It is an open-label single-arm study in patients with recent onset of schizophrenia schizophreniform disorder or schizoaffective disorder There are 3 phases Wash-out Phase of 7 days during which current psychotropic medications are discontinued Oral Treatment Phase beginning 1 week before the first injection and continuing 3 weeks thereafter during which risperidone tablets are taken and Long-Acting Injectable Treatment Phase during which injections are given every 2 weeks for 24 months Assessments of effectiveness include Positive and Negative Syndrome Scale PANSS a scale for the measurement of symptoms of schizophrenia time from initiation of treatment to relapse Calgary Depression Scale for Schizophrenia CDSS which assesses symptoms of major depressive disorder in patients with schizophrenia and Clinical Global Impression CGI scales Safety assessments include the incidence of adverse events and Extrapyramidal Symptom Rating Scale ESRS scores throughout the study clinical laboratory tests hematology and chemistry and vital signs pulse blood pressure temperature at stated intervals Risperidone oral tablets once daily 1 milligrammg 2mg or 3mg maximum from 1 week before first injection through 3 wks after Risperidone injections 25mg 375mg or 50mg max every 2 weeks for 24 months Doses may be increased or decreased at investigators discretion
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 |
|---|---|---|---|
| RIS-PSY-301 | OTHER | Janssen Pharmaceutica NV Belgium | None |