Trial Outcomes & Findings for An Efficacy and Safety Study of One Dosage of Paliperidone Extended Release (ER) in Treating Patients With Schizophrenia (NCT NCT00524043)
NCT ID: NCT00524043
Last Updated: 2014-06-04
Results Overview
The Positive and Negative Syndrome Scale (PANSS) is a tool used by psychiatrists to measure the symptoms of psychosis experienced by a patient with schizophrenia. It includes 30 items that produce a total score ranging from a minimum of 30 (indicating least severe symptoms of illness) to a maximum of 120 (indicating most severe symptoms of illness). A negative change in score from baseline to end point indicates improvement in the symptoms of illness.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
201 participants
Primary outcome timeframe
Baseline, 6 weeks
Results posted on
2014-06-04
Participant Flow
The study began on 21 September 2007 when the first patient was enrolled and ended on 20 November 2008 when the last patient left the study. The study was performed at medical clinics in the United States, India, and Taiwan.
Patients who wished to enter the study were screened and, if necessary, had prohibited medications (such as other antipsychotic drugs) washed out for 3 to 5 days before beginning the study. Eligible patients were excluded prior to beginning the study if, for example, they took a prohibited medication.
Participant milestones
| Measure |
Placebo
One oral placebo tablet daily for 6 weeks.
|
Paliperidone ER 6 mg
Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
|
Paliperidone ER 1.5 mg
Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
64
|
70
|
66
|
|
Overall Study
COMPLETED
|
34
|
42
|
35
|
|
Overall Study
NOT COMPLETED
|
30
|
28
|
31
|
Reasons for withdrawal
| Measure |
Placebo
One oral placebo tablet daily for 6 weeks.
|
Paliperidone ER 6 mg
Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
|
Paliperidone ER 1.5 mg
Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
15
|
13
|
14
|
|
Overall Study
Withdrawal by Subject
|
5
|
7
|
7
|
|
Overall Study
Adverse Event
|
5
|
2
|
7
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
3
|
|
Overall Study
Various (eg, incarceration)
|
2
|
1
|
0
|
Baseline Characteristics
An Efficacy and Safety Study of One Dosage of Paliperidone Extended Release (ER) in Treating Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Placebo
n=64 Participants
One oral placebo tablet daily for 6 weeks.
|
Paliperidone ER 6 mg
n=70 Participants
Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
|
Paliperidone ER 1.5 mg
n=66 Participants
Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=39 Participants
|
70 Participants
n=41 Participants
|
66 Participants
n=35 Participants
|
200 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 11.57 • n=39 Participants
|
40.3 years
STANDARD_DEVIATION 12.84 • n=41 Participants
|
41.3 years
STANDARD_DEVIATION 10.96 • n=35 Participants
|
39.4 years
STANDARD_DEVIATION 11.95 • n=31 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
16 Participants
n=35 Participants
|
57 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=39 Participants
|
47 Participants
n=41 Participants
|
50 Participants
n=35 Participants
|
143 Participants
n=31 Participants
|
|
Region of Enrollment
India
|
23 participants
n=39 Participants
|
25 participants
n=41 Participants
|
24 participants
n=35 Participants
|
72 participants
n=31 Participants
|
|
Region of Enrollment
Taiwan
|
7 participants
n=39 Participants
|
12 participants
n=41 Participants
|
9 participants
n=35 Participants
|
28 participants
n=31 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=39 Participants
|
33 participants
n=41 Participants
|
33 participants
n=35 Participants
|
100 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeksPopulation: The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.
The Positive and Negative Syndrome Scale (PANSS) is a tool used by psychiatrists to measure the symptoms of psychosis experienced by a patient with schizophrenia. It includes 30 items that produce a total score ranging from a minimum of 30 (indicating least severe symptoms of illness) to a maximum of 120 (indicating most severe symptoms of illness). A negative change in score from baseline to end point indicates improvement in the symptoms of illness.
Outcome measures
| Measure |
Placebo
n=63 Participants
One oral placebo tablet daily for 6 weeks.
|
Paliperidone ER 6 mg
n=70 Participants
Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
|
Paliperidone ER 1.5 mg
n=66 Participants
Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline in PANSS Total Score at the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment).
|
-11.7 units on a scale
Standard Deviation 22.84
|
-15.0 units on a scale
Standard Deviation 26.02
|
-8.9 units on a scale
Standard Deviation 25.41
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.
The Clinical Global Impression-Severity (CGI-S) rating scale is used by psychiatrists to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). The scale permits a global evaluation of the patient's condition at a given time.
Outcome measures
| Measure |
Placebo
n=63 Participants
One oral placebo tablet daily for 6 weeks.
|
Paliperidone ER 6 mg
n=70 Participants
Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
|
Paliperidone ER 1.5 mg
n=66 Participants
Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline to the End of the Double-blind Treatment Phase (Week 6 or the Last Assessment Obtained After the Baseline Assessment) in CGI-S
|
-1.0 units on a scale
Interval -2.0 to 2.0
|
-0.5 units on a scale
Interval -3.0 to 2.0
|
0.0 units on a scale
Interval -3.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.
The Personal and Social Performance (PSP) scale assesses the degree of difficulty (ranging from i \[absent\] to vi \[very severe\]) a patient exhibits over a 1-month period in socially useful activities, personal and social relationships, self care, and disturbing and aggressive behavior. The overall score ranges from 1 to 100. Patients with scores of 71 to 100 have a mild degree of difficulty; patients with scores from 31 to 70 have various degrees of disability; and patients with scores of 30 or less function so poorly as to require intensive supervision.
Outcome measures
| Measure |
Placebo
n=63 Participants
One oral placebo tablet daily for 6 weeks.
|
Paliperidone ER 6 mg
n=70 Participants
Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
|
Paliperidone ER 1.5 mg
n=66 Participants
Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in PSP Score
|
1.6 units on a scale
Standard Deviation 17.09
|
5.7 units on a scale
Standard Deviation 13.39
|
2.9 units on a scale
Standard Deviation 14.37
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.
The Medical Outcomes Study Short Form Health Survey-36 (MOS SF-36) is a measure of patient-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores are computed based on weighted combinations of the 8 subscale scores: the Physical Component Summary and the Mental Component Summary.
Outcome measures
| Measure |
Placebo
n=63 Participants
One oral placebo tablet daily for 6 weeks.
|
Paliperidone ER 6 mg
n=70 Participants
Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
|
Paliperidone ER 1.5 mg
n=66 Participants
Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Physical Component Summary Scale Score
|
0.4 units on a scale
Standard Deviation 6.94
|
0.6 units on a scale
Standard Deviation 9.45
|
-0.2 units on a scale
Standard Deviation 9.79
|
SECONDARY outcome
Timeframe: Baseline, 6 weeksPopulation: The intent-to-treat analysis set included all enrolled patients who received at least 1 dose of paliperidone ER or placebo and had both the baseline and at least 1 postbaseline efficacy assessment.
The MOS SF-36 is a measure of patient-reported health status. It is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores are computed based on weighted combinations of the 8 domain scores: the Physical Component Summary and the Mental Component Summary.
Outcome measures
| Measure |
Placebo
n=63 Participants
One oral placebo tablet daily for 6 weeks.
|
Paliperidone ER 6 mg
n=70 Participants
Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
|
Paliperidone ER 1.5 mg
n=66 Participants
Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
|
|---|---|---|---|
|
Change From Baseline to End Point (Week 6 or the Last Assessment After the Baseline Assessment) in MOS SF-36 Mental Component Summary Scale Score
|
3.5 units on a scale
Standard Deviation 13.14
|
6.1 units on a scale
Standard Deviation 13.39
|
2.1 units on a scale
Standard Deviation 11.71
|
Adverse Events
Placebo
Serious events: 7 serious events
Other events: 21 other events
Deaths: 0 deaths
Paliperidone ER 6 mg
Serious events: 5 serious events
Other events: 29 other events
Deaths: 0 deaths
Paliperidone ER 1.5 mg
Serious events: 7 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=64 participants at risk
One oral placebo tablet daily for 6 weeks.
|
Paliperidone ER 6 mg
n=70 participants at risk
Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
|
Paliperidone ER 1.5 mg
n=66 participants at risk
Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
|
|---|---|---|---|
|
Psychiatric disorders
Psychotic disorder
|
9.4%
6/64 • Number of events 6 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
2.9%
2/70 • Number of events 2 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
6.1%
4/66 • Number of events 4 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/64 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
2.9%
2/70 • Number of events 2 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
3.0%
2/66 • Number of events 2 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/64 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
0.00%
0/70 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
1.5%
1/66 • Number of events 1 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/64 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
1.4%
1/70 • Number of events 1 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
0.00%
0/66 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/64 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
1.4%
1/70 • Number of events 1 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
0.00%
0/66 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
|
Psychiatric disorders
Suicidal ideation
|
1.6%
1/64 • Number of events 1 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
0.00%
0/70 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
0.00%
0/66 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
Other adverse events
| Measure |
Placebo
n=64 participants at risk
One oral placebo tablet daily for 6 weeks.
|
Paliperidone ER 6 mg
n=70 participants at risk
Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
|
Paliperidone ER 1.5 mg
n=66 participants at risk
Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
|
|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
9.4%
6/64 • Number of events 11 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
10.0%
7/70 • Number of events 10 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
13.6%
9/66 • Number of events 11 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
|
Nervous system disorders
Headache
|
15.6%
10/64 • Number of events 11 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
11.4%
8/70 • Number of events 11 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
7.6%
5/66 • Number of events 7 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
|
Nervous system disorders
Tremor
|
3.1%
2/64 • Number of events 2 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
10.0%
7/70 • Number of events 7 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
3.0%
2/66 • Number of events 2 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
|
Nervous system disorders
Dizziness
|
1.6%
1/64 • Number of events 2 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
2.9%
2/70 • Number of events 2 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
7.6%
5/66 • Number of events 5 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
|
Nervous system disorders
Akathisia
|
1.6%
1/64 • Number of events 1 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
5.7%
4/70 • Number of events 4 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
0.00%
0/66 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
|
Gastrointestinal disorders
Constipation
|
6.2%
4/64 • Number of events 5 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
8.6%
6/70 • Number of events 9 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
4.5%
3/66 • Number of events 3 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/64 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
5.7%
4/70 • Number of events 5 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
1.5%
1/66 • Number of events 2 • Up to 8 weeks, including the screening period (2 to 6 days), the 6-week treatment period, and 1 week follow up. Monitoring for adverse events began after the patient was enrolled and continued until the last study-related procedure was performed.
There were 65 patients randomly assigned to treatment with placebo, but 1 patient in the Placebo group did not receive any treatment. Thus any adverse events experienced by this subject are not reported here.
|
Additional Information
Clinical Team Leader, Paliperidone
Johnson & Johnson Pharmaceutical Research & Development
Phone: 609 730-2436
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60