Ignite Creation Date:
2024-05-05 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00269919
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2005-12-22
Brief Title:
An Efficacy and Safety Study of Long-Term Risperidone Microspheres in Participants With Schizophrenia
Sponsor:
Janssen Korea Ltd Korea
Organization:
Janssen Korea Ltd Korea
Study Overview
Official Title:
Effect on Efficacy Safety and Quality of Life by Long-Term Treatment of Long-Acting Risperidone Microspheres in Patients With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2014-03
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 this study is to evaluate the long-term efficacy and safety of a long-acting injectable formulation of risperidone an antipsychotic medication and its influence on quality of life in participants with schizophrenia psychiatric disorder with symptoms of emotional instability detachment from reality often with delusions and hallucinations and withdrawal into the self
Detailed Description:
This is an open-label all people know the identity of the intervention single-arm and prospective study study following participants forward in time of risperidone microspheres in participants with schizophrenia Participants will be treated with intramuscular into a muscle injections of either 25 milligram mg or 375 mg or 50 mg of risperidone twice weekly every 2 weeks for 2 years The total duration of study will be 2 years The efficacy of participants will primarily be evaluated by total Positive and Negative Syndrome Scale PANSS score Participants quality of life and 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 |
|---|---|---|---|
| RIS-KOR-64 | None | None | None |