Trial Outcomes & Findings for An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia (NCT NCT00473434)
NCT ID: NCT00473434
Last Updated: 2012-12-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
64 participants
Primary outcome timeframe
Day 1 to Day 84
Results posted on
2012-12-05
Participant Flow
Participant milestones
| Measure |
Paliperidone Extended Release (ER)
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
Paliperidone Extended Release (ER)
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
|---|---|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Compliance
|
3
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Patient was selling medication to others
|
1
|
|
Overall Study
Safety evaluation
|
1
|
|
Overall Study
Reason not specified
|
6
|
|
Overall Study
Ceased in favor of Paliperidone
|
1
|
|
Overall Study
Switching to trial medication
|
1
|
|
Overall Study
No longer required
|
1
|
Baseline Characteristics
An Open Label Multicentre Study to Determine the Dose Distribution of Paliperidone ER in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Paliperidone Extended Release (ER)
n=64 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
|---|---|
|
Age Continuous
|
37.0 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 84Population: Intent-To-Treat (ITT) population
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=63 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 2
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 4
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 6
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 9
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 12
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 20
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 28
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 36
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 44
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 52
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84
|
6.9 mg
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 to Day 84Population: Intent-To-Treat (ITT) population
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=63 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 2
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 4
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 6
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 9
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 12
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 20
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 28
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 36
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 44
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 52
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 1 to Day 84
|
6 mg
Interval 3.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 57 to Day 84Population: Intent-To-Treat (ITT) population, excluding participants no longer participating in the study at Day 57
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=53 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 2
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 4
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 6
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 9
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 12
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 20
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 28
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 36
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 44
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 52
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Mean Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84
|
7.5 mg
Standard Deviation 2.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 57 to Day 84Population: Intent-To-Treat (ITT) population, excluding participants no longer participating in the study at Day 57
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=53 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 2
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 4
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 6
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 9
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 12
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 20
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 28
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 36
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 44
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 52
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Median Modal Prescribed Daily Dose of Paliperidone Extended Release (ER) From Day 57 to Day 84
|
6 mg
Interval 3.0 to 12.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 0 to Week 12Population: Intent-To-Treat (ITT) population
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=63 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 2
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 4
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 6
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 9
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 12
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 20
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 28
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 36
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 44
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 52
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Mean Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12
|
6.8 mg
Standard Deviation 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 0 to Week 12Population: Intent-To-Treat (ITT) population
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=63 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 2
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 4
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 6
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 9
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 12
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 20
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 28
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 36
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 44
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 52
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Median Overall Average Daily-prescribed Dose of Paliperidone Extended Release (ER) From Week 0 to Week 12
|
6 mg
Interval 3.6 to 10.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: All participants with evaluable data at each measurement time point
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients".
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=63 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 2
n=38 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 4
n=36 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 6
n=34 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 9
n=28 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 12
n=31 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 20
n=27 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 28
n=14 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 36
n=14 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 44
n=17 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 52
n=16 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Clinical Global Impression of Severity (CGI-S) Throughout the Study
|
3.7 scores on a scale
Standard Deviation 1.2
|
3.3 scores on a scale
Standard Deviation 1.1
|
3.2 scores on a scale
Standard Deviation 1.0
|
3.1 scores on a scale
Standard Deviation 1.1
|
2.8 scores on a scale
Standard Deviation 1.0
|
2.8 scores on a scale
Standard Deviation 1.0
|
2.9 scores on a scale
Standard Deviation 1.1
|
2.7 scores on a scale
Standard Deviation 1.1
|
2.7 scores on a scale
Standard Deviation 0.8
|
2.9 scores on a scale
Standard Deviation 1.2
|
2.7 scores on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 52 WeeksPopulation: All participants with evaluable data at each measurement time point
The GAF is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=63 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 2
n=38 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 4
n=36 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 6
n=34 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 9
n=28 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 12
n=31 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 20
n=27 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 28
n=14 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 36
n=14 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 44
n=17 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 52
n=16 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Global Assessment of Functioning (GAF) Throughout the Study
|
54.6 scores on a scale
Standard Deviation 14.7
|
58.9 scores on a scale
Standard Deviation 15.0
|
63.9 scores on a scale
Standard Deviation 15.3
|
63.9 scores on a scale
Standard Deviation 15.6
|
66.3 scores on a scale
Standard Deviation 13.8
|
65.4 scores on a scale
Standard Deviation 14.6
|
65.1 scores on a scale
Standard Deviation 14.7
|
71.1 scores on a scale
Standard Deviation 13.3
|
71.6 scores on a scale
Standard Deviation 14.9
|
69.0 scores on a scale
Standard Deviation 17.2
|
63.3 scores on a scale
Standard Deviation 15.7
|
SECONDARY outcome
Timeframe: 52 WeeksPopulation: All participants with evaluable data at each measurement time point
This Outcome Measure is intended to document only the hospitalizations associated with clinical deterioration, ie, when the patient needs to be hospitalized due to exacerbation of psychotic symptoms.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=63 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 2
n=38 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 4
n=36 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 6
n=34 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 9
n=28 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 12
n=31 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 20
n=27 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 28
n=14 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 36
n=14 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 44
n=17 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 52
n=16 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Percentage of Participants Presenting Clinical Deterioration Throughout the Study
Hospitalized
|
0 percentage of participants
14.7
|
5.3 percentage of participants
15.0
|
13.5 percentage of participants
15.3
|
5.9 percentage of participants
15.6
|
7.1 percentage of participants
13.8
|
3.2 percentage of participants
14.6
|
3.7 percentage of participants
14.7
|
0 percentage of participants
13.3
|
0 percentage of participants
14.9
|
0 percentage of participants
17.2
|
12.5 percentage of participants
15.7
|
|
The Percentage of Participants Presenting Clinical Deterioration Throughout the Study
Care Increase
|
0 percentage of participants
|
0 percentage of participants
|
5.4 percentage of participants
|
2.9 percentage of participants
|
3.6 percentage of participants
|
3.2 percentage of participants
|
7.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
5.9 percentage of participants
|
12.5 percentage of participants
|
|
The Percentage of Participants Presenting Clinical Deterioration Throughout the Study
Suicidal
|
4.8 percentage of participants
|
5.3 percentage of participants
|
8.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Participants Presenting Clinical Deterioration Throughout the Study
Violent
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
The Percentage of Participants Presenting Clinical Deterioration Throughout the Study
Self Injury
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
3.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 52 WeeksPopulation: All participants with evaluable data at each measurement time point
This outcome measure is intended to document all hospitalizations that occurred throughout the study.
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=63 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 2
n=38 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 4
n=36 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 6
n=34 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 9
n=28 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 12
n=31 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 20
n=27 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 28
n=14 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 36
n=14 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 44
n=17 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 52
n=16 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Hospitalizations Throughout the Study
|
15 events
14.7
|
2 events
15.0
|
6 events
15.3
|
2 events
15.6
|
3 events
13.8
|
1 events
14.6
|
1 events
14.7
|
0 events
13.3
|
0 events
14.9
|
1 events
17.2
|
2 events
15.7
|
SECONDARY outcome
Timeframe: 52 weeksPopulation: Participants who were hospitalized and had evaluable data at each measurement time point
Outcome measures
| Measure |
Paliperidone Extended Release (ER)
n=15 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 2
n=1 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 4
n=3 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 6
n=2 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 9
n=2 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 12
n=1 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 20
n=1 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 28
n=1 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 36
n=2 Participants
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 44
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
Week 52
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Length of Hospitalizations Throughout the Study
|
12.4 days
Standard Deviation 11.5
|
66 days
Standard Deviation 0
|
7.3 days
Standard Deviation 6.0
|
28.0 days
Standard Deviation 5.7
|
179.0 days
Standard Deviation 220.6
|
34 days
Standard Deviation 0
|
19 days
Standard Deviation 0
|
4 days
Standard Deviation 0
|
20.5 days
Standard Deviation 10.6
|
—
|
—
|
Adverse Events
Paliperidone Extended Release (ER)
Serious events: 27 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paliperidone Extended Release (ER)
n=64 participants at risk
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/64
|
|
General disorders
Lethargy
|
1.6%
1/64
|
|
Infections and infestations
Encephalitis viral
|
1.6%
1/64
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
1.6%
1/64
|
|
Injury, poisoning and procedural complications
Overdose
|
1.6%
1/64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
1.6%
1/64
|
|
Nervous system disorders
Dystonia
|
1.6%
1/64
|
|
Nervous system disorders
Extrapyramidal disorder
|
1.6%
1/64
|
|
Psychiatric disorders
Depression
|
3.1%
2/64
|
|
Psychiatric disorders
Hallucination, auditory
|
1.6%
1/64
|
|
Psychiatric disorders
Mental disorders
|
3.1%
2/64
|
|
Psychiatric disorders
Paranoia
|
3.1%
2/64
|
|
Psychiatric disorders
Psychotic disorder
|
1.6%
1/64
|
|
Psychiatric disorders
Schizoaffective disorder
|
3.1%
2/64
|
|
Psychiatric disorders
Schizophrenia
|
4.7%
3/64
|
|
Psychiatric disorders
Schizophrenia exacerbated
|
1.6%
1/64
|
|
Psychiatric disorders
Suicidal ideation
|
7.8%
5/64
|
Other adverse events
| Measure |
Paliperidone Extended Release (ER)
n=64 participants at risk
Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
|
|---|---|
|
Cardiac disorders
Dizziness
|
6.2%
4/64
|
|
Gastrointestinal disorders
Nausea
|
9.4%
6/64
|
|
Nervous system disorders
Headache
|
10.9%
7/64
|
|
Nervous system disorders
Sedation
|
6.2%
4/64
|
|
Nervous system disorders
Tremor
|
9.4%
6/64
|
|
Nervous system disorders
Vision blurred
|
6.2%
4/64
|
|
Psychiatric disorders
Akathisia
|
9.4%
6/64
|
|
Psychiatric disorders
Insomnia
|
15.6%
10/64
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
4/64
|
Additional Information
Regional Medical Affairs Therapeutic Lead Immunol
Jan-Cil Australia
Phone: 61 2 88753219
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60