Trial Outcomes & Findings for A Double-blind, Placebo-controlled Study of the Safety and Efficacy of Paliperidone Extended Release (ER) in the Treatment of Schizophrenia in Adolescent Patients (NCT NCT00518323)
NCT ID: NCT00518323
Last Updated: 2014-04-16
Results Overview
The Positive and Negative Syndrome Scale (PANSS) measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to the end.
COMPLETED
PHASE3
201 participants
6 weeks
2014-04-16
Participant Flow
Recruitment started 8 August 2007 in medical clinics located around the world. The study ended on 30 March 2009.
Subjects who were eligible for the study had their current disallowed psychotropic medications washed out prior to assignment to treatment groups. Subjects who violated inclusion criteria before assignment (eg, because they continued to take a disallowed medication) were to be removed from the study.
Participant milestones
| Measure |
Pali ER Low
Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
|
Pali ER Medium
Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
|
Pali ER High
Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
|
Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
54
|
48
|
48
|
51
|
|
Overall Study
COMPLETED
|
35
|
40
|
37
|
26
|
|
Overall Study
NOT COMPLETED
|
19
|
8
|
11
|
25
|
Reasons for withdrawal
| Measure |
Pali ER Low
Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
|
Pali ER Medium
Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
|
Pali ER High
Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
|
Placebo
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
14
|
2
|
4
|
20
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
3
|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
0
|
|
Overall Study
Prohibited medication and others
|
3
|
1
|
1
|
0
|
Baseline Characteristics
A Double-blind, Placebo-controlled Study of the Safety and Efficacy of Paliperidone Extended Release (ER) in the Treatment of Schizophrenia in Adolescent Patients
Baseline characteristics by cohort
| Measure |
Pali ER Low
n=54 Participants
Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
|
Pali ER Medium
n=48 Participants
Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
|
Pali ER High
n=48 Participants
Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
|
Placebo
n=51 Participants
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
54 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
201 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
15.1 years
STANDARD_DEVIATION 1.50 • n=5 Participants
|
15.3 years
STANDARD_DEVIATION 1.60 • n=7 Participants
|
15.5 years
STANDARD_DEVIATION 1.60 • n=5 Participants
|
15.7 years
STANDARD_DEVIATION 1.40 • n=4 Participants
|
15.4 years
STANDARD_DEVIATION 1.53 • n=21 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
118 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
9 participants
n=4 Participants
|
30 participants
n=21 Participants
|
|
Region of Enrollment
Ukraine
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
8 participants
n=4 Participants
|
34 participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Region of Enrollment
Russian Federation
|
22 participants
n=5 Participants
|
20 participants
n=7 Participants
|
19 participants
n=5 Participants
|
21 participants
n=4 Participants
|
82 participants
n=21 Participants
|
|
Region of Enrollment
India
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
11 participants
n=4 Participants
|
45 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.
The Positive and Negative Syndrome Scale (PANSS) measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to the end.
Outcome measures
| Measure |
Pali ER Low
n=54 Participants
Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
|
Pali ER Medium
n=48 Participants
Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
|
Pali ER High
n=47 Participants
Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
|
Placebo
n=51 Participants
|
|---|---|---|---|---|
|
Change in the PANSS Total Score From Baseline to the Last Postrandomization Assessment in the Double-blind Period of the Study.
|
-9.8 units on a scale
Standard Deviation 16.31
|
-17.3 units on a scale
Standard Deviation 14.33
|
-13.8 units on a scale
Standard Deviation 15.74
|
-7.9 units on a scale
Standard Deviation 20.15
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.
The CGI-S rating scale was used to assess the severity of a subject's overall clinical condition. Scores range from 1 to 7, where 1=best and 7=worst.
Outcome measures
| Measure |
Pali ER Low
n=54 Participants
Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
|
Pali ER Medium
n=48 Participants
Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
|
Pali ER High
n=47 Participants
Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
|
Placebo
n=51 Participants
|
|---|---|---|---|---|
|
Change From Baseline to End Point in Clinical Global Impression-Severity (CGI-S) Scale
|
0.0 units on a scale
Interval -3.0 to 1.0
|
-1.0 units on a scale
Interval -3.0 to 0.0
|
-1.0 units on a scale
Interval -3.0 to 1.0
|
0.0 units on a scale
Interval -3.0 to 1.0
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.
The CGAS score assesses psychological, social, and school functioning for children 6 to 17 years of age. Scores range from 1 to 100, where 100=best and 1=worst.
Outcome measures
| Measure |
Pali ER Low
n=54 Participants
Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
|
Pali ER Medium
n=48 Participants
Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
|
Pali ER High
n=47 Participants
Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
|
Placebo
n=51 Participants
|
|---|---|---|---|---|
|
Change From Baseline to End Point in Children's Global Assessment (CGAS) Score
|
4.4 units on a scale
Standard Deviation 10.72
|
13.1 units on a scale
Standard Deviation 12.07
|
8.6 units on a scale
Standard Deviation 11.18
|
5.0 units on a scale
Standard Deviation 13.82
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.
The sleep VAS for sleep quality is a scale for measuring the quality of sleep experienced by a patient. Scores range from 0 to 100, where 100=best and 0=worst.
Outcome measures
| Measure |
Pali ER Low
n=54 Participants
Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
|
Pali ER Medium
n=48 Participants
Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
|
Pali ER High
n=47 Participants
Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
|
Placebo
n=50 Participants
|
|---|---|---|---|---|
|
Change From Baseline to End Point in Sleep Visual Analog Scale (VAS) for Quality of Sleep.
|
6.6 units on a scale
Standard Deviation 24.57
|
16.0 units on a scale
Standard Deviation 27.06
|
14.4 units on a scale
Standard Deviation 22.72
|
-0.3 units on a scale
Standard Deviation 34.21
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: The number of participants in the intent-to-treat (ITT) analysis set was used. This set includes patients who received study drug and have at least 1 efficacy measurement. The Last Observation Carried Forward method was used for imputation; ie, the last measure for subjects who ended study early was carried forward as if they completed the study.
The sleep VAS for daytime drowsiness is a scale for measuring the drowsiness experienced by a patient. Scores range from 0 to 100, where 100=best and 0=worst.
Outcome measures
| Measure |
Pali ER Low
n=54 Participants
Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
|
Pali ER Medium
n=48 Participants
Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
|
Pali ER High
n=47 Participants
Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
|
Placebo
n=50 Participants
|
|---|---|---|---|---|
|
Change From Baseline to End Point in Sleep VAS for Daytime Drowsiness
|
-6.2 units on a scale
Standard Deviation 24.69
|
-7.2 units on a scale
Standard Deviation 25.22
|
1.0 units on a scale
Standard Deviation 29.55
|
-2.8 units on a scale
Standard Deviation 30.27
|
Adverse Events
Pali ER Low
Pali ER Medium
Pali ER High
Placebo
Serious adverse events
| Measure |
Pali ER Low
n=54 participants at risk
Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
|
Pali ER Medium
n=48 participants at risk
Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
|
Pali ER High
n=48 participants at risk
Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
|
Placebo
n=51 participants at risk
|
|---|---|---|---|---|
|
Psychiatric disorders
Schizophrenia
|
1.9%
1/54
|
0.00%
0/48
|
2.1%
1/48
|
0.00%
0/51
|
|
Psychiatric disorders
Agitation
|
1.9%
1/54
|
0.00%
0/48
|
0.00%
0/48
|
0.00%
0/51
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/54
|
0.00%
0/48
|
0.00%
0/48
|
2.0%
1/51
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/54
|
2.1%
1/48
|
0.00%
0/48
|
0.00%
0/51
|
Other adverse events
| Measure |
Pali ER Low
n=54 participants at risk
Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
|
Pali ER Medium
n=48 participants at risk
Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
|
Pali ER High
n=48 participants at risk
Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
|
Placebo
n=51 participants at risk
|
|---|---|---|---|---|
|
Nervous system disorders
Somnolence
|
5.6%
3/54
|
14.6%
7/48
|
20.8%
10/48
|
2.0%
1/51
|
|
Nervous system disorders
Akathisia
|
3.7%
2/54
|
8.3%
4/48
|
16.7%
8/48
|
0.00%
0/51
|
|
Nervous system disorders
Headache
|
9.3%
5/54
|
6.2%
3/48
|
10.4%
5/48
|
3.9%
2/51
|
|
Nervous system disorders
Cogwheel rigidity
|
0.00%
0/54
|
0.00%
0/48
|
8.3%
4/48
|
0.00%
0/51
|
|
Nervous system disorders
Dystonia
|
1.9%
1/54
|
2.1%
1/48
|
8.3%
4/48
|
0.00%
0/51
|
|
Nervous system disorders
Tremor
|
1.9%
1/54
|
8.3%
4/48
|
8.3%
4/48
|
0.00%
0/51
|
|
Psychiatric disorders
Insomnia
|
9.3%
5/54
|
6.2%
3/48
|
12.5%
6/48
|
21.6%
11/51
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/54
|
0.00%
0/48
|
8.3%
4/48
|
3.9%
2/51
|
|
Psychiatric disorders
Schizophrenia
|
9.3%
5/54
|
0.00%
0/48
|
4.2%
2/48
|
7.8%
4/51
|
|
Psychiatric disorders
Agitation
|
5.6%
3/54
|
2.1%
1/48
|
0.00%
0/48
|
3.9%
2/51
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/54
|
0.00%
0/48
|
8.3%
4/48
|
11.8%
6/51
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/54
|
6.2%
3/48
|
8.3%
4/48
|
9.8%
5/51
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/54
|
4.2%
2/48
|
8.3%
4/48
|
0.00%
0/51
|
|
Investigations
Weight increased
|
7.4%
4/54
|
4.2%
2/48
|
2.1%
1/48
|
0.00%
0/51
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.9%
1/54
|
0.00%
0/48
|
0.00%
0/48
|
5.9%
3/51
|
Additional Information
Compound Development Team Leader (CDTL)
Johnson & Johnson Pharmaceutical Research & Development
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60