Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272597
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2006-01-03
Brief Title:
Risperidone LA Heathcare Resource Study
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Risperidone Long Acting A Healthcare Resource Utilization Pilot Study
Status:
COMPLETED
Status Verified Date:
2017-11
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 primary objective of this pilot study is to evaluate the impact of switching 30 subjects from an existing antipsychotic to risperidone long acting on healthcare resource utilization The study will be a ten month open-label mirror-image pilot study Healthcare resource utilization during the 10 months prior to starting risperidone long acting will be retrospectively collected for all subjects period A at the beginning of the study The utilization of direct medical resources will also be collected for 10 months after initiation of risperidone long acting period B In this design the patients will serve as their own control
Detailed Description:
Screening Week -2 to Week 0 Days -14 to -1 In this phase the subject is required to be treated with oral risperidone as their only antipsychotic for a period of at least 5 days before entering the stabilization phase of the study Therefore
If the subject is currently treated with an antipsychotic other than risperidone the dosage will be tapered gradually and discontinued Simultaneously oral risperidone will be started at 2 mgday and increased to no more than 6 mgday The subject will be treated with risperidone monotherapy for at least five days prior to entering the stabilization phase of the study
On the other hand if the patient has already been treated for more than 5 days with risperidone monotherapy then heshe may enter the stabilization phase of the study immediately
Stabilization Phase Weeks 1 - 14 Days 0 - 98 The first three doses of risperidone long acting Days 0 14 and 28 will be 25 mg for all subjects At the time of the fourth injection Day 42 the dosage of risperidone long acting may be increased from 25 mg IM to 375 mg IM upon discretion of the treating physician Further increases in the dosage of risperidone long acting may be made at the time of the 6th and 8th injections Days 70 and 98 respectively In this case if the subject is currently receiving 25 mg heshe may be increased to 375 mg but not 50 mg Alternatively if the patient is currently receiving 375 mg then subject may be increased to the maximum recommended dosage of 50 mg IM every two weeks
To accommodate for the latency period ie the time for risperidone to be released from the microspheres and approach therapeutic plasma levels subjects entering into the study will continue on oral risperidone for the first three weeks Days 0-21 Temporary oral supplementation will also be permitted anytime during the stabilization phase of the study when considered by the treating physician to be clinically necessary for the treatment of breakthrough psychosis With only one exception the treating physician is not restricted from adding or discontinuing any pharmacological treatment deemed necessary for the clinical management of the subject The exception in this case prohibits the addition of another antipsychotic agent and applies only to the stabilization phase of the study
Maintenance Phase Weeks 15 - 38 Days 99 - 266 Patients that have shown adequate response to risperidone long acting will continue into the maintenance phase of the study From this point onwards the treating physician may change the dosage of risperidone long acting at any time as considered necessary Temporary oral supplementation will also be permitted during the maintenance phase when considered by the treating physician to be clinically necessary for the treatment of breakthrough psychosis Apart from the above the treating physician is not restricted from adding or discontinuing any pharmacological treatment including another antipsychotic deemed necessary for the clinical management of the subject
If the subject is currently treated with an antipsychotic other than risperidone the dosage will be tapered gradually and discontinued Simultaneously oral risperidone will be started at 2 mgday and increased to no more than 6 mgday The subject will be treated with risperidone monotherapy for at least five days prior to entering the stabilization phase of the study
On the other hand if the patient has already been treated for more than 5 days with risperidone monotherapy then heshe may enter the stabilization phase of the study immediately
Stabilization Phase Weeks 1 - 14 Days 0 - 98 The first three doses of risperidone long acting Days 0 14 and 28 will be 25 mg for all subjects At the time of the fourth injection Day 42 the dosage of risperidone long acting may be increased from 25 mg IM to 375 mg IM upon discretion of the treating physician Further increases in the dosage of risperidone long acting may be made at the time of the 6th and 8th injections Days 70 and 98 respectively In this case if the subject is currently receiving 25 mg heshe may be increased to 375 mg but not 50 mg Alternatively if the patient is currently receiving 375 mg then subject may be increased to the maximum recommended dosage of 50 mg IM every two weeks
To accommodate for the latency period ie the time for risperidone to be released from the microspheres and approach therapeutic plasma levels subjects entering into the study will continue on oral risperidone for the first three weeks Days 0-21 Temporary oral supplementation will also be permitted anytime during the stabilization phase of the study when considered by the treating physician to be clinically necessary for the treatment of breakthrough psychosis With only one exception the treating physician is not restricted from adding or discontinuing any pharmacological treatment deemed necessary for the clinical management of the subject The exception in this case prohibits the addition of another antipsychotic agent and applies only to the stabilization phase of the study
Maintenance Phase Weeks 15 - 38 Days 99 - 266 Patients that have shown adequate response to risperidone long acting will continue into the maintenance phase of the study From this point onwards the treating physician may change the dosage of risperidone long acting at any time as considered necessary Temporary oral supplementation will also be permitted during the maintenance phase when considered by the treating physician to be clinically necessary for the treatment of breakthrough psychosis Apart from the above the treating physician is not restricted from adding or discontinuing any pharmacological treatment including another antipsychotic deemed necessary for the clinical management of the subject
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