Trial Outcomes & Findings for A Study to Evaluate Participants Satisfaction, Quality of Life and Effectiveness of Flexible-Dose of Paliperidone Extended Release (ER) in Participants With Schizophrenia, Previously Treated With Risperidone (NCT NCT01010776)

Last Updated: 2013-11-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

223 participants

Primary outcome timeframe

Baseline and Week 26

Results posted on

2013-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Paliperidone Extended Release (ER) Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
Main Phase STARTED	223
Main Phase Treated	218
Main Phase COMPLETED	174
Main Phase NOT COMPLETED	49
In-Between Main Phase & Extension Phase STARTED	174
In-Between Main Phase & Extension Phase COMPLETED	159
In-Between Main Phase & Extension Phase NOT COMPLETED	15
Extension Phase STARTED	159
Extension Phase COMPLETED	156
Extension Phase NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Paliperidone Extended Release (ER) Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
Main Phase Withdrawal by Subject	14
Main Phase Lack of Efficacy	8
Main Phase Adverse Event	7
Main Phase Lost to Follow-up	6
Main Phase Non-compliance to study medication	5
Main Phase Selection failure	2
Main Phase Inform consent withdrawal	1
Main Phase Other	1
Main Phase Did not received study medication	5
In-Between Main Phase & Extension Phase Extension phase was optional	15
Extension Phase Other	3

Baseline Characteristics

A Study to Evaluate Participants Satisfaction, Quality of Life and Effectiveness of Flexible-Dose of Paliperidone Extended Release (ER) in Participants With Schizophrenia, Previously Treated With Risperidone

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paliperidone ER - Main Phase Plus Extension Phase n=218 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
Age Continuous	37.87 Years STANDARD_DEVIATION 11.01 • n=5 Participants
Age, Customized 18-21 years	14 Participants n=5 Participants
Age, Customized 22-29 years	50 Participants n=5 Participants
Age, Customized 30-39 years	51 Participants n=5 Participants
Age, Customized 40-49 years	67 Participants n=5 Participants
Age, Customized 50-60 years	35 Participants n=5 Participants
Age, Customized 61-69 years	1 Participants n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants
Sex: Female, Male Male	139 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	120 Participants n=5 Participants
Race/Ethnicity, Customized Black	52 Participants n=5 Participants
Race/Ethnicity, Customized Oriental	3 Participants n=5 Participants
Race/Ethnicity, Customized Mulatto	9 Participants n=5 Participants
Race/Ethnicity, Customized Brown	34 Participants n=5 Participants
Positive and Negative Syndrome Scale (PANSS) Total Score	94.49 Units on a scale STANDARD_DEVIATION 12.38 • n=5 Participants
Positive and Negative PANSS Subscales Score Positive PANSS Subscale Score	27.37 Units on a scale STANDARD_DEVIATION 6.48 • n=5 Participants
Positive and Negative PANSS Subscales Score Negative PANSS Subscale Score	19.76 Units on a scale STANDARD_DEVIATION 5.79 • n=5 Participants
Personal and Social Performance (PSP) Scale Score	44.39 Units on a scale STANDARD_DEVIATION 13.11 • n=5 Participants
Pittsburg Sleep Quality Index (PSQI)	6.7 Units on a scale STANDARD_DEVIATION 4.1 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 26

Population: The intent-to-treat for effectiveness (ITTe) population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Last Observation Carried Forward (LOCF) method was used.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) - Main Phase n=213 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase	-22.9 Units on a scale Standard Deviation 20.1 • Interval -25.6 to -20.2

PRIMARY outcome

Timeframe: Baseline and Week 52

Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) - Main Phase n=159 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase Baseline	93.25 Units on a scale Standard Deviation 11.6
Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase Change at Week 52	-26.4 Units on a scale Standard Deviation 17.5 • Interval -29.2 to -23.7

SECONDARY outcome

Timeframe: Week 26

Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.

Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. 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) - Main Phase n=213 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase	60.1 Percentage of participants Interval 53.2 to 66.7

SECONDARY outcome

Timeframe: Week 52

Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) - Main Phase n=159 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase	71.1 Percentage of participants Interval 63.4 to 78.0

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, 13 and 26

Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'N' specifies those participants who were evaluated for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.

The PANSS positive subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS negative subscale assesses seven 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) - Main Phase n=203 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 4: PANSS positive subscale (n=201)	-3.6 Units on a scale Standard Deviation 4.8 • Interval -24.0 to 9.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 4: PANSS negative subscale (n=201)	-3.6 Units on a scale Standard Deviation 4.8 • Interval -24.0 to 9.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 8: PANSS positive subscale (n=191)	-5.0 Units on a scale Standard Deviation 5.8 • Interval -25.0 to 20.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 8: PANSS negative subscale (n=191)	-5.0 Units on a scale Standard Deviation 5.8 • Interval -25.0 to 20.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 13: PANSS positive subscale (n=182)	-5.9 Units on a scale Standard Deviation 5.8 • Interval -25.0 to 9.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 13: PANSS negative subscale (n=182)	-5.9 Units on a scale Standard Deviation 5.8 • Interval -25.0 to 9.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 26: PANSS positive subscale (n=203)	-5.9 Units on a scale Standard Deviation 6.2 • Interval -25.0 to 14.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 26: PANSS negative subscale (n=203)	-5.9 Units on a scale Standard Deviation 6.2 • Interval -25.0 to 14.0

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, 13, 26, 39 and 52

Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'n' specifies those participants who were evaluated for this outcome measure at given time point.

The PANSS Positive Subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS Negative Subscale assesses seven 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) - Main Phase n=159 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Baseline: PANSS positive subscale (n=159)	26.65 Units on a scale Standard Deviation 6.20 • Interval 6.2 to
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Baseline: PANSS negative subscale (n=159)	19.25 Units on a scale Standard Deviation 5.86 • Interval 5.86 to
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 4: PANSS positive subscale (n=159)	-3.4 Units on a scale Standard Deviation 4.4 • Interval -14.0 to 9.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 4: PANSS negative subscale (n=159)	-3.4 Units on a scale Standard Deviation 4.4 • Interval -14.0 to 9.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 8: PANSS positive subscale (n=159)	-5.4 Units on a scale Standard Deviation 5.1 • Interval -18.0 to 9.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 8: PANSS negative subscale (n=159)	-5.4 Units on a scale Standard Deviation 5.1 • Interval -18.0 to 9.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 13: PANSS positive subscale (n=159)	-5.9 Units on a scale Standard Deviation 5.7 • Interval -18.0 to 9.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 13: PANSS negative subscale (n=159)	-5.9 Units on a scale Standard Deviation 5.7 • Interval -18.0 to 9.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 26: PANSS positive subscale (n=159)	-6.8 Units on a scale Standard Deviation 5.5 • Interval -20.0 to 9.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 26: PANSS negative subscale (n=159)	-6.8 Units on a scale Standard Deviation 5.5 • Interval -20.0 to 9.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 39: PANSS positive subcale (n=152)	-7.3 Units on a scale Standard Deviation 5.9 • Interval -25.0 to 4.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 39: PANSS negative subscale (n=152)	-7.3 Units on a scale Standard Deviation 5.9 • Interval -25.0 to 4.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 52: PANSS positive subscale (n=154)	-7.5 Units on a scale Standard Deviation 6.1 • Interval -25.0 to 10.0
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 52: PANSS negative subscale (n=154)	-7.5 Units on a scale Standard Deviation 6.1 • Interval -25.0 to 10.0

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, 13 and 26

The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) - Main Phase n=204 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 4 (n=201)	5.7 Units on a scale Standard Deviation 11.7
Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 8 (n=191)	8.3 Units on a scale Standard Deviation 12.8
Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 13 (n=182)	9.9 Units on a scale Standard Deviation 14.8
Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 26 (n=204)	10.4 Units on a scale Standard Deviation 14.9

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, 13, 26, 39 and 52

Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'n' specifies those participants who were evaluated for this outcome measure at given time point.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) - Main Phase n=159 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Baseline (n=159)	45.17 Units on a scale Standard Deviation 12.84
Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 4 (n=159)	5.3 Units on a scale Standard Deviation 9.6
Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 8 (n=159)	9.0 Units on a scale Standard Deviation 12.6
Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 13 (n=159)	9.7 Units on a scale Standard Deviation 14.4
Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 26 (n=159)	12.0 Units on a scale Standard Deviation 12.7
Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 39 (n=151)	12.6 Units on a scale Standard Deviation 14.2
Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 52 (n=155)	14.6 Units on a scale Standard Deviation 14.9

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, 13 and 26

The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) - Main Phase n=198 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase Baseline (n=198)	6.7 Units on a scale Standard Deviation 4.1
Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 4 (n=174)	-1.0 Units on a scale Standard Deviation 3.5
Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 8 (n=162)	-1.2 Units on a scale Standard Deviation 3.5
Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 13 (n=156)	-1.5 Units on a scale Standard Deviation 3.3
Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 26 (n=174)	-1.4 Units on a scale Standard Deviation 3.7

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, 13, 26, 39 and 52

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) - Main Phase n=148 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Baseline (n=148)	6.4 Units on a scale Standard Deviation 4.1
Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 4 (n=140)	-1.0 Units on a scale Standard Deviation 3.6
Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 8 (n=136)	-1.3 Units on a scale Standard Deviation 3.2
Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 13 (137)	-1.5 Units on a scale Standard Deviation 3.2
Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 26 (n=135)	-1.4 Units on a scale Standard Deviation 3.5
Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 39 (n=133)	-1.9 Units on a scale Standard Deviation 3.9
Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 52 (n=133)	-1.9 Units on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, 13 and 26

Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'n' specifies those participants who were evaluated for this outcome measure at given time point.

The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1="Normal, not at all ill" and a rating of 7 ="Among the most extremely ill participants". Higher scores indicate worsening.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) - Main Phase n=213 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Baseline: Borderline (n=213)	2 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Baseline: Slightly ill (n=213)	4 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Baseline: Moderately ill (n=213)	52 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Baseline: Markedly ill (n=213)	114 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Baseline: Severely ill (n=213)	40 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Baseline: Extremely ill (n=213)	1 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 4: Borderline (n=201)	4 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 4: Slightly ill (n=201)	25 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 4: Moderately ill (n=201)	87 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 4: Markedly ill (n=201)	61 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 4: Severely ill (n=201)	24 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 8: Borderline (n=191)	5 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 8: Slightly ill (n=191)	35 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 8: Moderately ill (n=191)	80 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 8: Markedly ill (n=191)	56 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 8: Severely ill (n=191)	15 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 8: extremely ill (n=191)	0 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 13: Normal, without any disease (n=182)	2 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 13: Borderline (n=182)	7 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 13: Slightly ill (n=182)	41 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 13: Moderately ill (n=182)	73 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 13: Markedly ill (n=182)	47 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 13: Severly ill (n=182)	12 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 26: Normal without any disease (n=204)	3 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 26: Borderline (n=204)	16 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 26: Slightly ill (n=204)	48 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 26: Moderately ill (n=204)	70 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 26: Markedely ill (n=204)	48 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase Week 26: Severely ill (n=204)	19 Participants

SECONDARY outcome

Timeframe: Week 39 and 52

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) - Main Phase n=155 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase Week 39: Normal without any disease (n=152)	2 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase Week 39: Borderline (n=152)	22 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase Week 39: Slightly ill (n=152)	41 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase Week 39: Moderately ill (n=152)	55 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase Week 39: Markedely ill (n=152)	22 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase Week 39: Severely ill (n=152)	10 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase Week 52: Borderline (n=155)	23 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase Week 52: Slightly ill (n=155)	37 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase Week 52: Moderately ill (n=155)	58 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase Week 52: Markedely ill (n=155)	24 Participants
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase Week 52: Severely ill (n=155)	10 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, 13 and 26

Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'n' specifies those participants who were evaluated for this outcome measure at given time point.

Participant's response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) - Main Phase n=213 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
Percentage of Participants With Treatment Satisfaction - Main Phase Baseline: Very good (n=213)	11.7 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Baseline: Good (n=213)	38.5 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Baseline: Moderate (n=213)	34.3 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Baseline: Bad (n=213)	12.7 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Baseline: Very bad (n=213)	2.8 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 4: Very good (n=200)	29.5 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 4: Good (n=200)	52.5 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 4: Moderate (n=200)	16.5 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 4: Bad (n=200)	1.0 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 4: Very bad (n=200)	0.5 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 8: Very good (n=190)	33.7 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 8: Good (n=190)	48.9 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 8: Moderate (n=190)	13.7 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 8: Bad (n=190)	3.7 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 13: Very good (n=182)	37.4 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 13: Good (n=182)	46.2 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 13: Moderate (n=182)	12.1 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 13: Bad (n=182)	3.8 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 13: Very bad (n=182)	0.5 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 26: Very good (n=204)	36.3 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 26: Good (n=204)	46.1 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 26: Moderate (n=204)	10.8 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 26: Bad (n=204)	4.4 Percentage of Participants
Percentage of Participants With Treatment Satisfaction - Main Phase Week 26: Very bad (n=204)	2.5 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, 13, 26, 39 and 52

Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. 'n' specifies those participants who were evaluated for this outcome measure at given time point.

Participant's response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) - Main Phase n=159 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Baseline: Very good (n=159)	13.2 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Baseline: Good (n=159)	40.9 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Baseline: Moderate (n=159)	32.1 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Baseline: Bad (n=159)	11.3 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Baseline: Very bad (n=159)	2.5 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 4: Very good (n=159)	31.4 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 4: Good (n=159)	54.1 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 4: Moderate (n=159)	13.8 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 4: Very bad (n=159)	0.6 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 8: Very good (n=159)	37.1 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 8: Moderate (n=159)	11.3 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 8: Bad (n=159)	3.1 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 13: Very good (n=159)	39.0 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 13: Good (n=159)	46.5 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 13: Moderate (n=159)	10.1 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 13: Bad (n=159)	3.8 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 13: Very bad (n=159)	0.6 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 26: Very good (n=159)	41.5 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 26: Good (n=159)	50.9 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 26: Moderate (n=159)	6.9 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 26: Very bad (n=159)	0.6 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 39: Very good (n=152)	38.8 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 39: Good (n=152)	51.3 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 39: Moderate (n=152)	7.2 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 39: Bad (n=152)	2.0 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 39: Very bad (n=152)	0.7 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 52: Very good (n=155)	41.3 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 52: Good (n=155)	43.2 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 52: Moderate (n=155)	12.9 Percentage of participants
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase Week 52: Bad (n=155)	2.6 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 26

The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) - Main Phase n=190 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
36-Item Short-Form Health Survey (SF-36) Score - Main Phase Baseline: Physical component summary	47.9 Units on a scale Standard Deviation 8.8
36-Item Short-Form Health Survey (SF-36) Score - Main Phase Baseline: Mental component summary	35.9 Units on a scale Standard Deviation 8.5
36-Item Short-Form Health Survey (SF-36) Score - Main Phase Week 26: Physical component summary	48.4 Units on a scale Standard Deviation 7.6
36-Item Short-Form Health Survey (SF-36) Score - Main Phase Week 26: Mental component summary	38.3 Units on a scale Standard Deviation 8.0

SECONDARY outcome

Timeframe: Baseline and Week 52

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) - Main Phase n=150 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase Baseline: Physical component summary	48.7 Units on a scale Standard Deviation 8.6
36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase Baseline: Mental component summary	35.7 Units on a scale Standard Deviation 8.5
36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase Week 52: Physical component summary	48.8 Units on a scale Standard Deviation 7.6
36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase Week 52: Mental component summary	38.5 Units on a scale Standard Deviation 8.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 4, 8, 13 and 26

Population: The safety analysis population included all the participants that received at least one dose of study medication and provided any post-baseline information. Here 'N' specifies those participants who were evaluated for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.

An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) - Main Phase n=215 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase Baseline (n=215)	1.30 Units on a scale Standard Deviation 1.99
Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 4 (n=201)	-0.40 Units on a scale Standard Deviation 1.23
Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 8 (n=189)	-0.45 Units on a scale Standard Deviation 1.47
Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 13 (n=182)	-0.63 Units on a scale Standard Deviation 1.76
Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase Change at Week 26 (n=201)	-0.6 Units on a scale Standard Deviation 1.71

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Week 4, 8, 13, 26, 39 and 52

Population: The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here 'N' specifies those participants who were evaluated for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.

Outcome measures

Outcome measures
Measure	Paliperidone Extended Release (ER) - Main Phase n=159 Participants Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.
Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Baseline (n=159)	1.41 Units on a scale Standard Deviation 2.14
Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 4 (n=159)	-0.51 Units on a scale Standard Deviation 1.31
Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 8 (n=159)	-0.49 Units on a scale Standard Deviation 1.56
Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 13 (n=159)	-0.68 Units on a scale Standard Deviation 1.85
Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 26 (n=158)	-0.77 Units on a scale Standard Deviation 1.87
Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 39 (n=151)	-0.81 Units on a scale Standard Deviation 1.97
Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase Change at Week 52 (n=154)	-0.75 Units on a scale Standard Deviation 1.94

Adverse Events

Paliperidone ER - Main Phase

Serious events: 14 serious events

Other events: 144 other events

Deaths: 0 deaths

Paliperidone ER - Extension Phase

Serious events: 3 serious events

Other events: 70 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Paliperidone ER - Main Phase n=215 participants at risk Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator's discretion.	Paliperidone ER - Extension Phase n=159 participants at risk Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
Metabolism and nutrition disorders Hypokalemia	0.47% 1/215 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.	0.00% 0/159 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.
Metabolism and nutrition disorders Hyponatremia	0.47% 1/215 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.	0.00% 0/159 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.
Psychiatric disorders Depressed mood	0.47% 1/215 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.	0.00% 0/159 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.
Psychiatric disorders Psychomotor agitation	0.47% 1/215 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.	0.00% 0/159 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.
Psychiatric disorders Psychotic disorder NOS	2.3% 5/215 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.	0.00% 0/159 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.
Psychiatric disorders Schizophrenia NOS	0.93% 2/215 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.	0.63% 1/159 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.
Psychiatric disorders Suicidal ideation	0.47% 1/215 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.	0.00% 0/159 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.
Skin and subcutaneous tissue disorders Skin lesion NOS	0.47% 1/215 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.	0.00% 0/159 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.
Surgical and medical procedures Hospitalization	0.93% 2/215 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.	0.00% 0/159 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.
Psychiatric disorders Somatoform disorder	0.47% 1/215 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.	0.00% 0/159 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/215 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.	0.63% 1/159 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.
Surgical and medical procedures Cholecystectomy	0.00% 0/215 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.	0.63% 1/159 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.
Pregnancy, puerperium and perinatal conditions Pregnancy NOS	0.00% 0/215 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.	0.63% 1/159 • Baseline up to Week 52 The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.

Other adverse events

Additional Information

Medical Group Manager

Jan-Cil Brazil

Phone: 55 11 3030-2770

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The Sponsor can require changes to the communication and can extend the embargo.
Publication restrictions are in place

Restriction type: OTHER