Trial Outcomes & Findings for Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia. (NCT NCT00488319)

Last Updated: 2017-02-10

Results Overview

A serious adverse event as defined by the International Conference on Harmonisation (ICH) is any untoward medical occurrence that at any dose results in death, is life-threatening (the subject was at risk of death at the time of the even; it does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

400 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2017-02-10

Participant Flow

This study evaluated the long-term (2 year) safety and tolerability of paliperidone extended release (ER) in adolescent patients with schizophrenia. This study was conducted from 27 June 2007 to 18 July 2012 at 55 centers in 10 countries. A total of 400 patients received at least 1 dose of the study drug and were included in the safety analysis.

Patients enrolled in this study came from 3 different sources: patients who enrolled directly, patients who were randomly assigned to placebo in the R076477PSZ3001 (NCT00518323) study, and patients who were randomly assigned to paliperidone ER in the R076477PSZ3001 (NCT00518323) study.

Participant milestones

Participant milestones
Measure	Placebo/Paliperidone Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
Overall Study STARTED	39	118	243
Overall Study COMPLETED	24	75	121
Overall Study NOT COMPLETED	15	43	122

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo/Paliperidone Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
Overall Study Adverse Event	1	2	23
Overall Study Lack of Efficacy	6	12	27
Overall Study Lost to Follow-up	3	5	16
Overall Study Withdrawal by Subject	5	20	44
Overall Study Other reasons for withdrawal	0	4	12

Baseline Characteristics

Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo/Paliperidone n=39 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=118 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=243 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=400 Participants Total of all reporting groups
Age, Categorical <=18 years	39 Participants n=5 Participants	118 Participants n=7 Participants	243 Participants n=5 Participants	400 Participants n=4 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
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	15.8 years STANDARD_DEVIATION 1.48 • n=5 Participants	15.3 years STANDARD_DEVIATION 1.59 • n=7 Participants	15.3 years STANDARD_DEVIATION 1.53 • n=5 Participants	15.4 years STANDARD_DEVIATION 1.55 • n=4 Participants
Gender Female	21 Participants n=5 Participants	44 Participants n=7 Participants	92 Participants n=5 Participants	157 Participants n=4 Participants
Gender Male	18 Participants n=5 Participants	74 Participants n=7 Participants	151 Participants n=5 Participants	243 Participants n=4 Participants
Region of Enrollment Bulgaria	0 participants n=5 Participants	0 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants
Region of Enrollment Estonia	0 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants
Region of Enrollment Finland	0 participants n=5 Participants	0 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants
Region of Enrollment India	6 participants n=5 Participants	23 participants n=7 Participants	35 participants n=5 Participants	64 participants n=4 Participants
Region of Enrollment Korea	0 participants n=5 Participants	0 participants n=7 Participants	40 participants n=5 Participants	40 participants n=4 Participants
Region of Enrollment Poland	0 participants n=5 Participants	0 participants n=7 Participants	47 participants n=5 Participants	47 participants n=4 Participants
Region of Enrollment Romania	2 participants n=5 Participants	8 participants n=7 Participants	10 participants n=5 Participants	20 participants n=4 Participants
Region of Enrollment Russia	18 participants n=5 Participants	51 participants n=7 Participants	40 participants n=5 Participants	109 participants n=4 Participants
Region of Enrollment Ukraine	8 participants n=5 Participants	22 participants n=7 Participants	18 participants n=5 Participants	48 participants n=4 Participants
Region of Enrollment United States of America	5 participants n=5 Participants	14 participants n=7 Participants	41 participants n=5 Participants	60 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: The safety analysis set was used for the safety analyses and included all enrolled participants who received at least 1 dose of the open-label study drug as recorded on the electronic case report form. This population was considered as evaluable participants.

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=39 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=118 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=243 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=400 Participants
The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability Treatment Emergent Adverse Events (TEAEs)	32 Number of Participants	88 Number of Participants	221 Number of Participants	341 Number of Participants
The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability Possibly-related TEAEs	24 Number of Participants	61 Number of Participants	185 Number of Participants	270 Number of Participants
The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability One or More Serious TEAEs	9 Number of Participants	4 Number of Participants	46 Number of Participants	59 Number of Participants

SECONDARY outcome

Timeframe: Baseline, Week 104 or the last post-baseline assessment

Population: The open-label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open-label study drug and had both the baseline and at least 1 postbaseline assessment in the open-label phase were included in this analysis set.

The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=39 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=117 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=237 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=393 Participants
Change From Open-label Baseline to Open-label Endpoint in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Scores - Last Observation Carried Forward	-18.9 Scores on a scale Standard Deviation 21.47	-12.6 Scores on a scale Standard Deviation 19.92	-22.4 Scores on a scale Standard Deviation 22.25	-19.1 Scores on a scale Standard Deviation 21.89

SECONDARY outcome

Timeframe: Baseline, Week 104 or the last post-baseline assessment

Population: The open label intent-to-treat analysis set was used for the efficacy analyses. All enrolled participants who received at least 1 dose of open label study drug and had both the baseline and at least 1 postbaseline assessment in the open label phase were included in this analysis set.

Neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale. PANSS scale provides a total score (sum of scores of all 30 items) and scores for 3 subscales, ie, positive (7 items), negative (7 items), and general psychopathology (16 items) subscales. Each item is scored on a scale of 1 (absent) to 7 (extreme). Positive Factor Score (range: 8 to 56): sum of select scores from positive, negative, and general psychopathology subscales. Negative Factor Score (range: 7 to 49): sum of select scores from negative and general psychopathology subscales. Disorganized Thoughts Factor Score (range: 7 to 49): sum of select scores from positive, negative, and general psychopathology subscales. Uncontrolled Hostility/Excitement Factor Score (range: 4 to 28): sum of select scores from positive and general psychopathology subscales. Anxiety/Depression Factor Score (range: 4 to 28): sum of select scores from general psychopathology subscale. Higher scores indicate worsening.

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=39 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=117 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=237 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=393 Participants
Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward Positive Symptoms	-5.1 Scores on a scale Standard Deviation 6.45	-3.4 Scores on a scale Standard Deviation 6.11	-7.0 Scores on a scale Standard Deviation 7.12	-5.7 Scores on a scale Standard Deviation 6.94
Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward Negative Symptoms	-4.3 Scores on a scale Standard Deviation 6.30	-3.8 Scores on a scale Standard Deviation 4.80	-5.7 Scores on a scale Standard Deviation 6.68	-5.0 Scores on a scale Standard Deviation 6.18
Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward Disorganized Thoughts	-4.8 Scores on a scale Standard Deviation 5.57	-3.3 Scores on a scale Standard Deviation 4.41	-4.9 Scores on a scale Standard Deviation 5.52	-4.4 Scores on a scale Standard Deviation 5.25
Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward Uncontrolled Hostility/Excitement	-2.6 Scores on a scale Standard Deviation 4.17	-1.2 Scores on a scale Standard Deviation 4.41	-2.1 Scores on a scale Standard Deviation 4.68	-1.9 Scores on a scale Standard Deviation 4.56
Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward Anxiety/Depression	-2.1 Scores on a scale Standard Deviation 3.35	-0.9 Scores on a scale Standard Deviation 3.41	-2.8 Scores on a scale Standard Deviation 3.61	-2.2 Scores on a scale Standard Deviation 3.62

SECONDARY outcome

Timeframe: Baseline, Week 104 or the last post-baseline assessment

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 participant. 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 participants". Higher scores indicate worsening.

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=39 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=117 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=237 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=393 Participants
Change From Open-label Baseline to Open-label Endpoint in the Clinical Global Impression Severity (CGI-S) Scale - Last Observation Carried Forward	-1.0 Scores on a scale Interval -3.0 to 2.0	-1.0 Scores on a scale Interval -3.0 to 3.0	-1.0 Scores on a scale Interval -5.0 to 3.0	-1.0 Scores on a scale Interval -5.0 to 3.0

SECONDARY outcome

Timeframe: Baseline, Week 104 or the last post-baseline assessment

The CGAS is a 100 point rating scale which measures the psychological, social, and school functioning for children 6 to 17 years of age. The score ranges from 1 to 100, divided into 10 equal intervals to rate the impairment level of general functioning (poor to superior functioning). Higher scores denote better functioning.

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=39 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=117 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=237 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=393 Participants
Change From Open-label Baseline to Open-label Endpoint in the Children's Global Assessment Scale (CGAS) - Last Observation Carried Forward	11.3 Scores on a scale Standard Deviation 16.65	8.7 Scores on a scale Standard Deviation 16.02	15.6 Scores on a scale Standard Deviation 17.77	13.1 Scores on a scale Standard Deviation 17.39

SECONDARY outcome

Timeframe: Baseline, Week 24

A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores \[mean=50, SD=10 range 1-100\]; z-scores \[mean=0, SD=1, and can be positive or negative\] or scaled scores \[mean=10, SD=3, and can be positive or negative\]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=29 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=88 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=154 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=271 Participants
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Motor Speed Domain Test Variable, Finger Tapping Dominant- and Non-Dominant Hand, Scaled - Last Observation Carried Forward Finger Tapping Dominant Hand	0.2 Scores on a scale Standard Deviation 1.15	0.1 Scores on a scale Standard Deviation 1.65	0.3 Scores on a scale Standard Deviation 1.36	0.2 Scores on a scale Standard Deviation 1.44
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Motor Speed Domain Test Variable, Finger Tapping Dominant- and Non-Dominant Hand, Scaled - Last Observation Carried Forward Finger Tapping Non Dominant Hand	0.2 Scores on a scale Standard Deviation 1.20	0.4 Scores on a scale Standard Deviation 2.05	0.2 Scores on a scale Standard Deviation 1.55	0.3 Scores on a scale Standard Deviation 1.69

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=27 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=90 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=143 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=260 Participants
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Coding, Scaled - Last Observation Carried Forward	1.9 Scores on a scale Standard Deviation 3.25	1.5 Scores on a scale Standard Deviation 2.54	0.1 Scores on a scale Standard Deviation 2.60	0.8 Scores on a scale Standard Deviation 2.75

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=28 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=95 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=159 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=282 Participants
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Digit Span, Scaled - Last Observation Carried Forward	0.9 Scores on a scale Standard Deviation 2.42	0.8 Scores on a scale Standard Deviation 2.81	0.8 Scores on a scale Standard Deviation 2.71	0.8 Scores on a scale Standard Deviation 2.71

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=1 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=9 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=17 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=27 Participants
Change From Open-label Baseline to Open-label - Cognitive Domain: Verbal Learning and Memory Domain Test Variable Wide Range Assessment of Memory and Learning Story - Total, Scaled - Last Observation Carried Forward	0 Scores on a scale Standard Deviation NA Number of participants analyzed is 1	0.6 Scores on a scale Standard Deviation 3.57	1.7 Scores on a scale Standard Deviation 1.36	1.3 Scores on a scale Standard Deviation 2.33

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=1 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=11 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=18 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=30 Participants
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Verbal Learning and Memory Domain Test Variable California Verbal Learning Test-Total Trials, Scaled - Last Observation Carried Forward	29.0 Scores on a scale Standard Deviation NA Number of participants analyzed is 1	3.5 Scores on a scale Standard Deviation 12.29	8.2 Scores on a scale Standard Deviation 12.19	7.2 Scores on a scale Standard Deviation 12.70

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=29 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=92 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=150 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=271 Participants
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Visual Learning and Memory Domain Test Variable, Rey Complex Figure Test - Total, Scaled - Last Observation Carried Forward	-0.5 Scores on a scale Standard Deviation 1.56	-0.3 Scores on a scale Standard Deviation 2.02	0.3 Scores on a scale Standard Deviation 2.39	0.0 Scores on a scale Standard Deviation 2.21

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=29 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=91 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=149 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=269 Participants
Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Social Cognition Domain Test Variable - Theory of Mind-Total - Last Observation Carried Forward	3.4 Scores on a scale Standard Deviation 7.04	4.1 Scores on a scale Standard Deviation 6.68	5.6 Scores on a scale Standard Deviation 9.20	4.9 Scores on a scale Standard Deviation 8.23

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=2 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=15 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=21 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=38 Participants
Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Trials Part A Time: Scaled - Last Observation Carried Forward	1.8 Scores on a scale Standard Deviation 1.06	-2.3 Scores on a scale Standard Deviation 4.97	1.5 Scores on a scale Standard Deviation 7.66	0.0 Scores on a scale Standard Deviation 6.69

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=21 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=58 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=101 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=180 Participants
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Child Color Trials Test 1 Time: Scaled - Last Observation Carried Forward	0.0 Scores on a scale Standard Deviation 20.82	3.6 Scores on a scale Standard Deviation 11.90	6.2 Scores on a scale Standard Deviation 14.41	4.7 Scores on a scale Standard Deviation 14.62

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=21 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=78 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=79 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=178 Participants
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Phonetic Verbal Fluency: Scaled - Last Observation Carried Forward	0.3 Scores on a scale Standard Deviation 1.48	0.2 Scores on a scale Standard Deviation 1.07	0.5 Scores on a scale Standard Deviation 1.09	0.4 Scores on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=20 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=76 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=78 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=174 Participants
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Semantic Verbal Fluency, Scaled - Last Observation Carried Forward	0.2 Scores on a scale Standard Deviation 1.23	0.1 Scores on a scale Standard Deviation 0.82	0.2 Scores on a scale Standard Deviation 0.90	0.2 Scores on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=15 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=18 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=33 Participants
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable, Trials Part B Time, Scaled - Last Observation Carried Forward	—	0.2 Scores on a scale Standard Deviation 2.67	0.7 Scores on a scale Standard Deviation 2.53	0.5 Scores on a scale Standard Deviation 2.57

SECONDARY outcome

Timeframe: Baseline, Week 24

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=15 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=66 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=109 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=190 Participants
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable - Wisconsin Card Sort Test-Total Errors: Scaled - Last Observation Carried Forward	4.3 Scores on a scale Standard Deviation 11.13	4.6 Scores on a scale Standard Deviation 11.09	7.0 Scores on a scale Standard Deviation 13.16	5.9 Scores on a scale Standard Deviation 12.32

SECONDARY outcome

Timeframe: Baseline, Week 104 or the last post-baseline assessment

Sleep VAS is a self administered scale that rates the quality of sleep and daytime drowsiness. Participants make a mark on a line to represent how well they have slept in the previous 7 days ("very badly" to "very well") and how often they have felt drowsy within the previous 7 days ("not at all" to "all the time"). The score for each item ranges from 0 to 100 mm. For quality of sleep, a score of 0 indicates "Very badly" and a score of 100 indicates "Very well." For daytime drowsiness, a score of 0 indicates "Not at all" and a score of 100 indicates "All the time." Improvement of the condition is indicated by the positive change for the quality of sleep and the negative change for the daytime drowsiness.

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=36 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=116 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=223 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=375 Participants
Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Quality of Sleep - Last Observation Carried Forward	8.2 Scores on a scale Standard Deviation 30.51	2.7 Scores on a scale Standard Deviation 18.48	9.8 Scores on a scale Standard Deviation 32.47	7.4 Scores on a scale Standard Deviation 28.78

SECONDARY outcome

Timeframe: Baseline, Week 104 or the last post-baseline assessment

Outcome measures

Outcome measures
Measure	Placebo/Paliperidone n=36 Participants Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=116 Participants Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=223 Participants Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Total n=375 Participants
Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Daytime Drowsiness - Last Observation Carried Forward	-7.4 Scores on a scale Standard Deviation 18.83	-5.1 Scores on a scale Standard Deviation 22.39	-3.9 Scores on a scale Standard Deviation 32.30	-4.6 Scores on a scale Standard Deviation 28.42

Adverse Events

Placebo/Paliperidone

Serious events: 9 serious events

Other events: 26 other events

Deaths: 0 deaths

Paliperidone (Double-blind)/Paliperidone

Serious events: 4 serious events

Other events: 74 other events

Deaths: 0 deaths

Paliperidone (No Double-blind)/Paliperidone

Serious events: 46 serious events

Other events: 192 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo/Paliperidone n=39 participants at risk Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=118 participants at risk Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=243 participants at risk Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
Blood and lymphatic system disorders Lymphadenitis	2.6% 1/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.00% 0/243 • Up to 2 years
Cardiac disorders Bradycardia	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Gastrointestinal disorders Gastritis	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Gastrointestinal disorders Vomiting	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
General disorders Irritability	2.6% 1/39 • Up to 2 years	0.85% 1/118 • Up to 2 years	0.00% 0/243 • Up to 2 years
Infections and infestations Appendicitis	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.82% 2/243 • Up to 2 years
Infections and infestations Sinusitis	2.6% 1/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.00% 0/243 • Up to 2 years
Injury, poisoning and procedural complications Frostbite	0.00% 0/39 • Up to 2 years	0.85% 1/118 • Up to 2 years	0.00% 0/243 • Up to 2 years
Injury, poisoning and procedural complications Spinal Compression Fracture	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Injury, poisoning and procedural complications Upper Limb Fracture	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Nervous system disorders Akathisia	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Nervous system disorders Dystonia	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.82% 2/243 • Up to 2 years
Nervous system disorders Hypokinesia	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Nervous system disorders Oromandibular Dystonia	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Nervous system disorders Speech Disorder	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Psychiatric disorders Adjustment Disorder	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Psychiatric disorders Aggression	0.00% 0/39 • Up to 2 years	0.85% 1/118 • Up to 2 years	1.2% 3/243 • Up to 2 years
Psychiatric disorders Agitation	0.00% 0/39 • Up to 2 years	0.85% 1/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Psychiatric disorders Anxiety	2.6% 1/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	1.2% 3/243 • Up to 2 years
Psychiatric disorders Delusion	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.82% 2/243 • Up to 2 years
Psychiatric disorders Delusion of Grandeur	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Psychiatric disorders Depressed Mood	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Psychiatric disorders Depression	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Psychiatric disorders Depressive Symptom	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Psychiatric disorders Flight of Ideas	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Psychiatric disorders Hallucination	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.82% 2/243 • Up to 2 years
Psychiatric disorders Hallucination, Auditory	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.82% 2/243 • Up to 2 years
Psychiatric disorders Intentional Self-Injury	2.6% 1/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.00% 0/243 • Up to 2 years
Psychiatric disorders Mania	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Psychiatric disorders Oppositional Defiant Disorder	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Psychiatric disorders Paranoia	0.00% 0/39 • Up to 2 years	0.85% 1/118 • Up to 2 years	0.00% 0/243 • Up to 2 years
Psychiatric disorders Psychotic Disorder	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.82% 2/243 • Up to 2 years
Psychiatric disorders Schizophrenia	17.9% 7/39 • Up to 2 years	1.7% 2/118 • Up to 2 years	8.6% 21/243 • Up to 2 years
Psychiatric disorders Schizophrenia, Paranoid Type	2.6% 1/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.82% 2/243 • Up to 2 years
Psychiatric disorders Schizophrenia, Undifferentiated Type	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Psychiatric disorders Self Injurious Behaviour	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Psychiatric disorders Suicidal Ideation	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	2.9% 7/243 • Up to 2 years
Psychiatric disorders Suicide Attempt	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	1.2% 3/243 • Up to 2 years
Psychiatric disorders Tension	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Renal and urinary disorders Haematuria	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Renal and urinary disorders Nephrolithiasis	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years
Skin and subcutaneous tissue disorders Ingrowing Nail	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	0.41% 1/243 • Up to 2 years

Other adverse events

Other adverse events
Measure	Placebo/Paliperidone n=39 participants at risk Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (Double-blind)/Paliperidone n=118 participants at risk Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.	Paliperidone (No Double-blind)/Paliperidone n=243 participants at risk Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
Cardiac disorders Palpitations	5.1% 2/39 • Up to 2 years	0.85% 1/118 • Up to 2 years	1.2% 3/243 • Up to 2 years
Cardiac disorders Tachycardia	5.1% 2/39 • Up to 2 years	0.85% 1/118 • Up to 2 years	3.3% 8/243 • Up to 2 years
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/39 • Up to 2 years	1.7% 2/118 • Up to 2 years	5.8% 14/243 • Up to 2 years
Gastrointestinal disorders Nausea	2.6% 1/39 • Up to 2 years	2.5% 3/118 • Up to 2 years	11.1% 27/243 • Up to 2 years
Gastrointestinal disorders Salivary Hypersecretion	5.1% 2/39 • Up to 2 years	7.6% 9/118 • Up to 2 years	9.1% 22/243 • Up to 2 years
Gastrointestinal disorders Vomiting	0.00% 0/39 • Up to 2 years	2.5% 3/118 • Up to 2 years	9.1% 22/243 • Up to 2 years
General disorders Asthenia	7.7% 3/39 • Up to 2 years	2.5% 3/118 • Up to 2 years	1.2% 3/243 • Up to 2 years
Infections and infestations Bronchitis	5.1% 2/39 • Up to 2 years	0.85% 1/118 • Up to 2 years	0.82% 2/243 • Up to 2 years
Infections and infestations Nasopharyngitis	7.7% 3/39 • Up to 2 years	15.3% 18/118 • Up to 2 years	13.2% 32/243 • Up to 2 years
Infections and infestations Rhinitis	5.1% 2/39 • Up to 2 years	1.7% 2/118 • Up to 2 years	3.7% 9/243 • Up to 2 years
Investigations Weight Increased	5.1% 2/39 • Up to 2 years	10.2% 12/118 • Up to 2 years	24.3% 59/243 • Up to 2 years
Metabolism and nutrition disorders Increased Appetite	5.1% 2/39 • Up to 2 years	2.5% 3/118 • Up to 2 years	3.7% 9/243 • Up to 2 years
Musculoskeletal and connective tissue disorders Muscle Rigidity	2.6% 1/39 • Up to 2 years	5.1% 6/118 • Up to 2 years	7.8% 19/243 • Up to 2 years
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	5.8% 14/243 • Up to 2 years
Nervous system disorders Akathisia	0.00% 0/39 • Up to 2 years	8.5% 10/118 • Up to 2 years	17.3% 42/243 • Up to 2 years
Nervous system disorders Dizziness	10.3% 4/39 • Up to 2 years	6.8% 8/118 • Up to 2 years	5.3% 13/243 • Up to 2 years
Nervous system disorders Dystonia	2.6% 1/39 • Up to 2 years	5.1% 6/118 • Up to 2 years	5.3% 13/243 • Up to 2 years
Nervous system disorders Headache	10.3% 4/39 • Up to 2 years	7.6% 9/118 • Up to 2 years	18.9% 46/243 • Up to 2 years
Nervous system disorders Sedation	2.6% 1/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	5.8% 14/243 • Up to 2 years
Nervous system disorders Somnolence	25.6% 10/39 • Up to 2 years	15.3% 18/118 • Up to 2 years	18.5% 45/243 • Up to 2 years
Nervous system disorders Tremor	2.6% 1/39 • Up to 2 years	10.2% 12/118 • Up to 2 years	12.8% 31/243 • Up to 2 years
Psychiatric disorders Anxiety	10.3% 4/39 • Up to 2 years	5.9% 7/118 • Up to 2 years	5.8% 14/243 • Up to 2 years
Psychiatric disorders Insomnia	17.9% 7/39 • Up to 2 years	9.3% 11/118 • Up to 2 years	16.5% 40/243 • Up to 2 years
Psychiatric disorders Schizophrenia	5.1% 2/39 • Up to 2 years	8.5% 10/118 • Up to 2 years	5.8% 14/243 • Up to 2 years
Psychiatric disorders Suicidal Ideation	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	12.3% 30/243 • Up to 2 years
Reproductive system and breast disorders Galactorrhoea	7.7% 3/39 • Up to 2 years	3.4% 4/118 • Up to 2 years	3.7% 9/243 • Up to 2 years
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	5.1% 2/39 • Up to 2 years	1.7% 2/118 • Up to 2 years	2.9% 7/243 • Up to 2 years
Skin and subcutaneous tissue disorders Acne	0.00% 0/39 • Up to 2 years	0.00% 0/118 • Up to 2 years	5.8% 14/243 • Up to 2 years

Additional Information

Director Clinical Research

Johnson & Johnson Research & Development, LLC

Phone: 1-609-730-6771

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. Expedited reviews will be arranged for abstracts, poster presentations, or other materials. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER