Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246246
Status:
COMPLETED
Last Update Posted:
2011-02-11
First Post:
2005-10-28
Brief Title:
A Randomized Open-label Trial of Long-acting Injectable Risperidone Versus Oral Antipsychotic Medication in Patients With Bipolar Disorder
Sponsor:
Janssen-Ortho Inc Canada
Organization:
Janssen-Ortho Inc Canada
Study Overview
Official Title:
A Randomized Open-label Trial of RISPERDAL CONSTA Versus Oral Antipsychotic Care in Subjects With Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2011-02
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 determine the safety and effectiveness of a long-acting injectable formulation of risperidone in stable bipolar patients randomly switched from their current add-on oral antipsychotic olanzapine risperidone or quetiapine therapy to long-acting injectable risperidone The patients switched to long-acting injectable risperidone will be compared to patients who continue on their oral antipsychotic treatment regimen
Detailed Description:
This an open-label randomized study Approximately 40 stable bipolar patients who are on an atypical antipsychotic olanzapine risperidone quetiapine plus adjunct bipolar treatment consisting of a maximum or two of lithium valproate or lamotrigine and if applicable one antidepressant will be randomized to two arms In one arm 25 milligrams of long-acting injectable risperidone will replace the oral atypical antipsychotic as adjunct therapy and in the other arm patients will continue with their current atypical antipsychotic therapy Trial duration is 6 months In the long-acting injectable risperidone arm the oral atypical antipsychotic will be continued as supplementation for 3 weeks after the first injection of long-acting risperidone and then discontinued Investigators based upon the patients response may increase the dose of injectable risperidone to 375 mg after 6 weeks on the 25-mg dose and to 50 mg after at least 4 weeks on the 375-mg dose Risperidone oral supplementation is allowed In the oral antipsychotic only arm the oral atypical antipsychotic dose can also be increased as required The primary efficacy outcome will be measured by changes in the Clinical Global Impression - Severity of Illness subscale CGI-S from baseline to endpoint and will be compared between the treatment groups Safety will be monitored throughout the study The primary hypothesis is that patients switched to long-acting injectable risperidone will be able to tolerate this formulation of risperidone and maintain or even improve their reduction in bipolar symptomatology compared with baseline and compared with subjects who continue in the oral antipsychotic arm The secondary hypothesis is that patients switched to long-acting injectable risperidone will have a longer time to intervention for a mood episode either mania or depression as compared with subjects who continue in the oral antipsychotic arm Risperidone formulated for intramuscular injection 25 mg every 2 weeks Patients treated with injectable risperidone continue their original oral atypical antipsychotic AAP dose for 3 weeks Investigators at their discretion may increase the dose of injectable risperidone to 375 mg after 6 weeks on the 25-mg dose and to 50 mg after at least 4 weeks on the 375-mg dose Study duration is 6 months
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