Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00309699
Status:
COMPLETED
Last Update Posted:
2014-06-20
First Post:
2006-03-31
Brief Title:
A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release ER Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
Randomized Double-Blind Active- and Placebo-Controlled Parallel Group Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone Compared With Flexibly-Dosed Quetiapine and Placebo in the Treatment of Acute Manic and Mixed Episodes in Bipolar Disorder
Status:
COMPLETED
Status Verified Date:
2014-06
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 effectiveness and safety of flexible-doses paliperidone ER 3 to 12 mg as needed compared with placebo over 3 weeks in patients with Bipolar I Disorder who are experiencing an acute manic or mixed episode This study will also evaluate the effects of paliperidone ER on global functioning and will compare the effectiveness of flexible doses of paliperidone ER to that of quetiapine over 12 weeks
Detailed Description:
Several treatments are available for the treatment of acute manic and mixed episodes associated with bipolar disorder Some of these treatments although used for many years are associated with well-known problems such as poor tolerability significant toxicities narrow therapeutic ranges and drug interactions Often several drugs must be used in combination to achieve the best clinical effect More recently a group of compounds known as atypical antipsychotics such as risperidone have been licensed for use in this indication Paliperidone has similar properties as risperidone and is expected to be as effective in the treatment of acute manic and mixed episodes associated with bipolar disorder Paliperidone ER has been shown to be effective in schizophrenia and it has an improved drug delivery system with a reduced potential for drug interactions
Study drug tablets are designed to deliver the appropriate amount of drug 3 mg or 6 mg using a Push-Pull delivery system based on a patented oral osmotic pump technology OROS that allows the drug to be delivered at a relatively controlled rate for 24 hours This study will test flexibly-dosed paliperidone ER 3 to 12 mgday compared with placebo inactive substance or flexibly-dosed quetiapine 400 to 800 mgday There are 4 parts to the study a screening and washout phase that lasts up to 7 days to determine if patients are eligible for the study and to discontinue all current medications a double-blind neither the patient nor the physician knows whether drug or placebo and what dosage is being taken acute treatment phase that lasts for 3 weeks a 9-week double-blind maintenance phase to see if the effects of paliperidone are maintained over a longer period and a follow-up phase that lasts about 1 week after the final visit or early withdrawal from the study During the acute treatment phase patients are randomly assigned to receive treatment with placebo 3 to 12 mgday of paliperidone ER or 400 to 800 mgday of quetiapine The dosage of paliperidone ER or quetiapine may be adjusted to meet the patients needs Patients who receive placebo during the acute phase first 3 weeks will receive paliperidone ER beginning with 6 mgday during the maintenance phase last 9 weeks All other patients receive the same drug ie either paliperidone ER or quetiapine during both phases The dosages during the acute phase begin at 6 mgday for paliperidone ER and 100 mgday for quetiapine and may be adjusted thereafter by the study investigator to meet individual patient needs after a forced titration of quetiapine to 400 mgday Patients will be hospitalized for at least the first 7 days of double-blind treatment and may be discharged on the seventh day and followed as outpatients based on the judgment of the study doctor End-of-studyearly withdrawal procedures will be done after the last dose of study drug has been received and blood samples have been taken or if a patient withdraws early Patients will have a follow-up visit with safety evaluations approximately 1 week later The study including the screening and washout phases will last approximately 98 days or 14 weeks
Effectiveness will be primarily determined by the change in the total Young Mania Rating Scale YMRS score from the beginning baseline to the end of the acute treatment phase of the study The YMRS is an 11-item established measure used to evaluate manic symptoms A secondary measure of effectiveness is the change in the Global Assessment of Functioning GAF scale from baseline to the end of the acute treatment phase of the study Other measures of effectiveness include the change from baseline to end of the maintenance phase in total YMRS score the time to onset of therapeutic effect responder rate defined as 50 or more reduction from baseline in YMRS score and changes from baseline to the end of the acute treatment phase in all other assessment scales Additional assessment scales will be used to evaluate the clinical progress of the patient psychotic features in bipolar disorder quality of sleep and daytime drowsiness health-related function and rate the severity of the patients bipolar disorder Safety will be evaluated by the frequency severity and timing of side effects clinical laboratory tests including pregnancy tests 12-lead electrocardiograms ECGs vital signs measurements and physical and neurological examinations
The study hypotheses for the primary and secondary effectiveness measures are that 1 flexibly dosed dosages of 3 to 12 mgday paliperidone ER have more effect than placebo on the change from baseline in the YMRS total score at the end of 3 weeks of treatment 2 flexibly-dosed paliperidone ER has more effect than placebo on the change from baseline in GAF score at the end of 3 weeks of treatment and 3 flexibly-dosed paliperidone ER is not worse than quetiapine in the change in YMRS score at 12 weeks The potential effect on the variation in genes related to paliperidone ER may be evaluated separately in patients who consent to DNA deoxyribonucleic acid testing All study drug will be administered twice daily The dosages during the acute phase first 3 weeks begin at 6 mgday for paliperidone ER and 400 mgday for quetiapine after a forced titration from 100 mgday and may be adjusted thereafter by the investigator to meet individual patient needs within the ranges of 3-12 mgday and 400-800 mgday Patients who receive placebo during the acute phase will receive paliperidone ER starting with 6 mgday during the maintenance phase last 9 weeks
Study drug tablets are designed to deliver the appropriate amount of drug 3 mg or 6 mg using a Push-Pull delivery system based on a patented oral osmotic pump technology OROS that allows the drug to be delivered at a relatively controlled rate for 24 hours This study will test flexibly-dosed paliperidone ER 3 to 12 mgday compared with placebo inactive substance or flexibly-dosed quetiapine 400 to 800 mgday There are 4 parts to the study a screening and washout phase that lasts up to 7 days to determine if patients are eligible for the study and to discontinue all current medications a double-blind neither the patient nor the physician knows whether drug or placebo and what dosage is being taken acute treatment phase that lasts for 3 weeks a 9-week double-blind maintenance phase to see if the effects of paliperidone are maintained over a longer period and a follow-up phase that lasts about 1 week after the final visit or early withdrawal from the study During the acute treatment phase patients are randomly assigned to receive treatment with placebo 3 to 12 mgday of paliperidone ER or 400 to 800 mgday of quetiapine The dosage of paliperidone ER or quetiapine may be adjusted to meet the patients needs Patients who receive placebo during the acute phase first 3 weeks will receive paliperidone ER beginning with 6 mgday during the maintenance phase last 9 weeks All other patients receive the same drug ie either paliperidone ER or quetiapine during both phases The dosages during the acute phase begin at 6 mgday for paliperidone ER and 100 mgday for quetiapine and may be adjusted thereafter by the study investigator to meet individual patient needs after a forced titration of quetiapine to 400 mgday Patients will be hospitalized for at least the first 7 days of double-blind treatment and may be discharged on the seventh day and followed as outpatients based on the judgment of the study doctor End-of-studyearly withdrawal procedures will be done after the last dose of study drug has been received and blood samples have been taken or if a patient withdraws early Patients will have a follow-up visit with safety evaluations approximately 1 week later The study including the screening and washout phases will last approximately 98 days or 14 weeks
Effectiveness will be primarily determined by the change in the total Young Mania Rating Scale YMRS score from the beginning baseline to the end of the acute treatment phase of the study The YMRS is an 11-item established measure used to evaluate manic symptoms A secondary measure of effectiveness is the change in the Global Assessment of Functioning GAF scale from baseline to the end of the acute treatment phase of the study Other measures of effectiveness include the change from baseline to end of the maintenance phase in total YMRS score the time to onset of therapeutic effect responder rate defined as 50 or more reduction from baseline in YMRS score and changes from baseline to the end of the acute treatment phase in all other assessment scales Additional assessment scales will be used to evaluate the clinical progress of the patient psychotic features in bipolar disorder quality of sleep and daytime drowsiness health-related function and rate the severity of the patients bipolar disorder Safety will be evaluated by the frequency severity and timing of side effects clinical laboratory tests including pregnancy tests 12-lead electrocardiograms ECGs vital signs measurements and physical and neurological examinations
The study hypotheses for the primary and secondary effectiveness measures are that 1 flexibly dosed dosages of 3 to 12 mgday paliperidone ER have more effect than placebo on the change from baseline in the YMRS total score at the end of 3 weeks of treatment 2 flexibly-dosed paliperidone ER has more effect than placebo on the change from baseline in GAF score at the end of 3 weeks of treatment and 3 flexibly-dosed paliperidone ER is not worse than quetiapine in the change in YMRS score at 12 weeks The potential effect on the variation in genes related to paliperidone ER may be evaluated separately in patients who consent to DNA deoxyribonucleic acid testing All study drug will be administered twice daily The dosages during the acute phase first 3 weeks begin at 6 mgday for paliperidone ER and 400 mgday for quetiapine after a forced titration from 100 mgday and may be adjusted thereafter by the investigator to meet individual patient needs within the ranges of 3-12 mgday and 400-800 mgday Patients who receive placebo during the acute phase will receive paliperidone ER starting with 6 mgday during the maintenance phase last 9 weeks
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 |
|---|---|---|---|
| R076477BIM3002 | None | None | None |