Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236353
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2005-10-07
Brief Title:
Evaluation of the Efficacy and Safety of Risperidone Injections Given Once a Month to Adults With Schizophrenia or Schizoaffective Disorder
Sponsor:
Janssen LP
Organization:
Janssen LP
Study Overview
Official Title:
An Open-label Study of the Efficacy and Safety of RISPERDAL Long-acting Microspheres RISPERDAL CONSTA Administered Once Monthly in Adults With Schizophrenia or Schizoaffective Disorder
Status:
COMPLETED
Status Verified Date:
2011-03
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 assess the effectiveness and safety of long-acting risperidone given as a once monthly injection to adult patients with schizophrenia or schizoaffective disorder
Detailed Description:
Risperidone taken by mouth on a daily basis has been an effective treatment for schizophrenia and schizoaffective disorder Risperidone is also available in a long-acting injectable form so that patients can take their medicine by bi-weekly injections This study will assess the effectiveness and safety of long-acting risperidone injection given once a month instead of every two weeks based on previous studies with dosing every 2 weeks During the four-week lead-in phase patients will receive one 50-milligram injection every two weeks for two doses Patients continue to take their prescribed dose of risperidone tablets from 2 to 6 milligrams per day for the first 14 days After the first month patients will receive one 50-milligram injection once a month for 48 weeks This dose can be increased to 75 milligrams if patient meets relapse criteria and is willing to stay in the trial Patients will be asked questions to help determine how well the monthly injections are working Laboratory tests including drug levels physical examinations and adverse event reporting will be performed to determine the safety of the monthly injections Risperidone oral tablets 2 to 6 milligrams per day for first 2 weeks long-acting risperidone intramuscular injections 50 mg in 2 milliliters of liquid every 2 weeks for 1 month then injections once a month for 48 weeks Monthly injection dose may be increased to 75 mg in 2-mL if needed
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