Trial Outcomes & Findings for An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia (NCT NCT01009047)

Last Updated: 2013-06-21

Results Overview

The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

228 participants

Primary outcome timeframe

Baseline and Day 56

Results posted on

2013-06-21

Participant Flow

Participant milestones

Participant milestones
Measure	Paliperidone Extended Release (ER) Paliperidone ER administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.	Aripiprazole Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Overall Study STARTED	113	115
Overall Study COMPLETED	85	89
Overall Study NOT COMPLETED	28	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Paliperidone Extended Release (ER) Paliperidone ER administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.	Aripiprazole Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Overall Study Adverse Event	5	0
Overall Study Lost to Follow-up	0	2
Overall Study Lack of Efficacy	4	11
Overall Study Withdrawal by consent	16	11
Overall Study Other	3	2

Baseline Characteristics

An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paliperidone Extended Release (ER) n=112 Participants Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.	Aripiprazole n=114 Participants Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.	Total n=226 Participants Total of all reporting groups
Age Continuous	15.3 Years STANDARD_DEVIATION 1.46 • n=99 Participants	15.4 Years STANDARD_DEVIATION 1.45 • n=107 Participants	15.3 Years STANDARD_DEVIATION 1.46 • n=206 Participants
Sex: Female, Male Female	39 Participants n=99 Participants	38 Participants n=107 Participants	77 Participants n=206 Participants
Sex: Female, Male Male	73 Participants n=99 Participants	76 Participants n=107 Participants	149 Participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline and Day 56

Population: The intent-to-treat (ITT) population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) n=112 Participants Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.	Aripiprazole n=114 Participants Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 Change at Day 56	-19.3 Units on a scale Standard Deviation 13.80	-19.8 Units on a scale Standard Deviation 14.56
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 Baseline	89.6 Units on a scale Standard Deviation 12.22	92.0 Units on a scale Standard Deviation 12.09

SECONDARY outcome

Timeframe: Baseline and Day 182

Population: The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used.

The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) n=112 Participants Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.	Aripiprazole n=114 Participants Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Change From Baseline in PANSS Total Score at Day 182 Change at Day 182	-25.6 Units on a scale Standard Deviation 16.88	-26.8 Units on a scale Standard Deviation 18.82
Change From Baseline in PANSS Total Score at Day 182 Baseline	89.6 Units on a scale Standard Deviation 12.22	92.0 Units on a scale Standard Deviation 12.09

SECONDARY outcome

Timeframe: Baseline, Day 56 and Day 182

The PANSS negative subscale based on marder factor assesses 7 negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) n=112 Participants Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.	Aripiprazole n=114 Participants Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182 Change at Day 182	-6.0 Units on a scale Standard Deviation 5.51	-6.2 Units on a scale Standard Deviation 5.84
Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182 Baseline	23.2 Units on a scale Standard Deviation 4.92	23.3 Units on a scale Standard Deviation 4.54
Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182 Change at Day 56	-4.3 Units on a scale Standard Deviation 4.56	-4.7 Units on a scale Standard Deviation 4.61

SECONDARY outcome

Timeframe: Baseline, Day 56 and 182

The subscales based on marder factors are: positive symptoms, disorganised thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for Uncontrolled hostility/excitement and anxiety/depression. Higher score indicate worsening.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) n=112 Participants Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.	Aripiprazole n=114 Participants Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Change From Baseline in Other Marder Factors Scores at Day 56 and 182 Change at Day 182: Anxiety/depression	-3.0 Units on a scale Standard Deviation 3.29	-3.2 Units on a scale Standard Deviation 3.17
Change From Baseline in Other Marder Factors Scores at Day 56 and 182 Baseline: Positive symptoms	24.6 Units on a scale Standard Deviation 4.08	24.9 Units on a scale Standard Deviation 4.32
Change From Baseline in Other Marder Factors Scores at Day 56 and 182 Change at Day 56: Positive symptoms	-6.1 Units on a scale Standard Deviation 4.96	-5.6 Units on a scale Standard Deviation 4.83
Change From Baseline in Other Marder Factors Scores at Day 56 and 182 Change at Day 182: Positive symptoms	-7.8 Units on a scale Standard Deviation 5.82	-7.8 Units on a scale Standard Deviation 6.03
Change From Baseline in Other Marder Factors Scores at Day 56 and 182 Baseline: Negative symptoms	23.2 Units on a scale Standard Deviation 4.92	23.3 Units on a scale Standard Deviation 4.54
Change From Baseline in Other Marder Factors Scores at Day 56 and 182 Change at Day 56: Negative symptoms	-4.3 Units on a scale Standard Deviation 4.56	-4.7 Units on a scale Standard Deviation 4.61
Change From Baseline in Other Marder Factors Scores at Day 56 and 182 Change at Day 182: Negative symptoms	-6.0 Units on a scale Standard Deviation 5.51	-6.2 Units on a scale Standard Deviation 5.84
Change From Baseline in Other Marder Factors Scores at Day 56 and 182 Baseline: Disorganized thoughts	21.4 Units on a scale Standard Deviation 4.40	22.1 Units on a scale Standard Deviation 3.86
Change From Baseline in Other Marder Factors Scores at Day 56 and 182 Change at Day 56: Disorganized thoughts	-4.0 Units on a scale Standard Deviation 3.34	-4.1 Units on a scale Standard Deviation 3.40
Change From Baseline in Other Marder Factors Scores at Day 56 and 182 Change at Day 182: Disorganized thoughts	-5.5 Units on a scale Standard Deviation 4.18	-5.7 Units on a scale Standard Deviation 4.46
Change From Baseline in Other Marder Factors Scores at Day 56 and 182 Baseline: Uncontrolled hostility	10.7 Units on a scale Standard Deviation 3.19	11.7 Units on a scale Standard Deviation 3.48
Change From Baseline in Other Marder Factors Scores at Day 56 and 182 Change at Day 56: Uncontrolled hostility	-2.5 Units on a scale Standard Deviation 2.67	-2.9 Units on a scale Standard Deviation 3.05
Change From Baseline in Other Marder Factors Scores at Day 56 and 182 Change at Day 182: Uncontrolled hostility	-3.2 Units on a scale Standard Deviation 3.11	-3.8 Units on a scale Standard Deviation 3.97
Change From Baseline in Other Marder Factors Scores at Day 56 and 182 Baseline: Anxiety/depression	9.7 Units on a scale Standard Deviation 3.17	10.0 Units on a scale Standard Deviation 3.26
Change From Baseline in Other Marder Factors Scores at Day 56 and 182 Change at Day 56: Anxiety/depression	-2.4 Units on a scale Standard Deviation 3.08	-2.6 Units on a scale Standard Deviation 2.81

SECONDARY outcome

Timeframe: Baseline, Day 56 and 182

The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme).

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) n=112 Participants Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.	Aripiprazole n=114 Participants Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 Baseline: Positive Subscale	21.5 Units on a scale Standard Deviation 4.14	22.5 Units on a scale Standard Deviation 4.26
Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 Change at Day 56: Positive Subscale	-6.4 Units on a scale Standard Deviation 4.54	-6.2 Units on a scale Standard Deviation 4.91
Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 Change at Day 182: Positive Subscale	-8.0 Units on a scale Standard Deviation 5.16	-8.3 Units on a scale Standard Deviation 6.09
Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 Baseline: Negative Subscale	23.8 Units on a scale Standard Deviation 4.55	24.2 Units on a scale Standard Deviation 4.32
Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 Change at Day 56: Negative Subscale	-4.2 Units on a scale Standard Deviation 4.25	4.5 Units on a scale Standard Deviation 4.25
Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 Change at Day 182: Negative Subscale	-5.7 Units on a scale Standard Deviation 5.15	-6.1 Units on a scale Standard Deviation 5.47
Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 Baseline: General Psychopathology	44.3 Units on a scale Standard Deviation 7.47	45.3 Units on a scale Standard Deviation 7.01
Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 Change at Day 56: General Psychopathology	-8.7 Units on a scale Standard Deviation 7.35	-9.1 Units on a scale Standard Deviation 7.25
Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 Change at Day 182: General Psychopathology	-11.9 Units on a scale Standard Deviation 9.02	-12.4 Units on a scale Standard Deviation 9.41

SECONDARY outcome

Timeframe: Day 56 and 182

Clinical stability is defined as a decrease of 20 percent or more from Baseline in PANSS total score and CGI-S score less than or equal to 4 at Days 56 and 182, no hospitalizations due to psychiatric illness and no emergence of clinically significant suicidal or homicidal ideation during the maintenance phase.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) n=112 Participants Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.	Aripiprazole n=114 Participants Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Number of Participants With Clinical Stability	58 Participants	68 Participants

SECONDARY outcome

Timeframe: Baseline, Day 56 and 182

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	Paliperidone Extended Release (ER) n=112 Participants Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.	Aripiprazole n=114 Participants Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182 Baseline	4.0 Units on a scale Interval 3.0 to 6.0	4.0 Units on a scale Interval 3.0 to 6.0
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182 Change at Day 56	-1.0 Units on a scale Interval -4.0 to 0.0	-1 Units on a scale Interval -3.0 to 1.0
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182 Change at Day 182	-1.0 Units on a scale Interval -4.0 to 1.0	-1.0 Units on a scale Interval -4.0 to 1.0

SECONDARY outcome

Timeframe: Baseline, Day 56 and Day 182

The PSP scale assesses degree of a participants' dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numerical score to rate degree of difficulty (1=absent to 6=very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score (total score ranges from 1 to 100, divided into 10 equal intervals). Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) n=112 Participants Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.	Aripiprazole n=114 Participants Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182 Change at Day 56	12.2 Units on a Scale Standard Deviation 11.72	12.2 Units on a Scale Standard Deviation 10.17
Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182 Baseline	49.8 Units on a Scale Standard Deviation 10.32	49.2 Units on a Scale Standard Deviation 10.21
Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182 Change at Day 182	17.1 Units on a Scale Standard Deviation 14.46	17.1 Units on a Scale Standard Deviation 14.03

SECONDARY outcome

Timeframe: Day 56 and 182

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) n=112 Participants Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.	Aripiprazole n=114 Participants Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Number of Participants With PANSS Response Day 56	76 Participants	87 Participants
Number of Participants With PANSS Response Day 182	86 Participants	93 Participants

Adverse Events

Paliperidone Extended Release (ER)

Serious events: 7 serious events

Other events: 63 other events

Deaths: 0 deaths

Aripiprazole

Serious events: 7 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Paliperidone Extended Release (ER) n=113 participants at risk Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.	Aripiprazole n=114 participants at risk Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Psychiatric disorders Agitation	0.88% 1/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	0.88% 1/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Psychiatric disorders Anxiety	0.88% 1/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	0.00% 0/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Psychiatric disorders Schizophrenia	0.88% 1/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	3.5% 4/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Psychiatric disorders Schizophrenia, paranoid type	0.88% 1/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	0.00% 0/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Psychiatric disorders Suicide attempt	0.88% 1/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	0.00% 0/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Infections and infestations Sinusitis	0.88% 1/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	0.00% 0/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Infections and infestations Upper respiratory infection	0.00% 0/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	0.88% 1/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Psychiatric disorders Psychotic disorder	0.88% 1/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	0.88% 1/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.

Other adverse events

Other adverse events
Measure	Paliperidone Extended Release (ER) n=113 participants at risk Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.	Aripiprazole n=114 participants at risk Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
Psychiatric disorders Schizophrenia	2.7% 3/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	8.8% 10/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Gastrointestinal disorders Vomiting	7.1% 8/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	0.88% 1/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Nervous system disorders Headache	10.6% 12/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	4.4% 5/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Nervous system disorders Akathisia	11.5% 13/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	7.9% 9/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Nervous system disorders Somnolence	10.6% 12/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	10.5% 12/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Nervous system disorders Tremor	10.6% 12/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	9.6% 11/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Nervous system disorders Sedation	5.3% 6/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	2.6% 3/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Psychiatric disorders Insomnia	5.3% 6/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	7.9% 9/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Gastrointestinal disorders Nausea	3.5% 4/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	6.1% 7/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Investigations Weight increased	10.6% 12/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	6.1% 7/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
General disorders Asthenia	5.3% 6/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	0.88% 1/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Musculoskeletal and connective tissue disorders Muscle rigidity	6.2% 7/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	2.6% 3/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.
Metabolism and nutrition disorders Decreased appetite	1.8% 2/113 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.	5.3% 6/114 • Baseline up to Week 26 The safety population included all randomly assigned participants who received at least 1 dose of double-blind study drug. A total of 113 participants in the paliperidone ER group and 114 participants in the aripiprazole group received at least 1 dose of double-blind study medication and were included in the safety analysis set.

Additional Information

Senior Director, Clinical Leader

Janssen Research & Development, LLC

Phone: +1-609-730-2436

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. If requested by the Sponsor, the Investigator will withhold it up to an additional 60 days to allow for filing of a patent application. The Sponsor will not change or suppress the scientific content. For multi-center study, results may not be published before the primary endpoints of a study have been published.
Publication restrictions are in place

Restriction type: OTHER