PANDORA: PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia

• Sponsor: Janssen Korea, Ltd., Korea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00761189
• Collaborator: (none)
• Enrollment: 491
• Locations: 20
• Arm: 1
• Duration (Months): 28.9
• Patients Per Site: 24.6
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy of paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Paliperidone	Phase 4

Detailed Description

This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center), prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended Release(ER) in participants with schizophrenia. The total study duration will be approximately of 104 weeks per participant. The study consists of following parts: Screening (that is, 14 days before study commences on Day 1); acute Treatment phase (single-oral dose of paliperidone for 12 weeks, dose ranging from 3 to 12 milligram); Extension phase 1 (12 weeks) and Maintenance treatment which will be followed by additional Extension phase 2 and long-term maintenance treatment. Efficacy of the participants will primarily be evaluated by Clinical Global Impression-Improvement (CGI-I) scale score. Participants' safety will be monitored throughout the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 491 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label, Prospective, Non-comparative Study to Evaluate Flexible Dose of Paliperidone Extended-Release and Clinical Response in the Treatment of Subjects With Schizophrenia
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paliperidone Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.	Drug: Paliperidone; Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.; Other Names: R076477 Invega extended-Release (ER) tablet

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population [Week 12]

   The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

2. Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population [Week 12]

   The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

Secondary Outcome Measures

1. Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population [Baseline, Week 4 and 12]

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

2. Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population [Baseline, Week 4 and Week 12]

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

3. Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population [Week 12]

   Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until Week 12 are reported here.

4. Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population [Week 12]

   Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until week 12 are reported here.

5. Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population [Baseline, Week 4 and 12]

   The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).

6. Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population [Baseline, Week 4 and 12]

   The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).

7. Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population [Baseline, Week 2, 4, 8 and 12]

   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.

8. Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population [Baseline, Week 2, 4, 8 and 12]

   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.

9. Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population [Week 12]

   The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

10. Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population [Week 12]

    The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening

• Childbearing potential women who consent to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)

• Participants who are capable of and willing to fill out the questionnaire for themselves

• Participants who are compliant with self-medication or can receive consistent help or support

• Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)

Exclusion Criteria:

• Participants with the past history of neuroleptic malignant syndrome (NMS)

• Participants with Treatment Resistance history who have failed to be properly treated with more than two other kinds of antipsychotic agents (at least 4 weeks of the therapeutic dose administration)

• Participants with severe (pathologic or iatrogenic) gastrointestinal stenosis or participants who can not swallow the drug whole (The study drug must not be chewed, divided, melted or grinded because it can impact the study drug release profile.)

• Participants who have been exposed to the study drug within one month before screening

• Participants with significant risk including suicide or aggressive behavior

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Bucheon-Si Gyeonggi-Do		Korea, Republic of
2		Changnyung		Korea, Republic of
3		Chungnam		Korea, Republic of
4		Chunjoo		Korea, Republic of
5		Daejeon		Korea, Republic of
6		Daejun		Korea, Republic of
7		Geonggi-Do		Korea, Republic of
8		Gyeonggi-Do		Korea, Republic of
9		Incheon		Korea, Republic of
10		Inchun		Korea, Republic of
11		Jinju		Korea, Republic of
12		Kwangjoo		Korea, Republic of
13		Kyounggi		Korea, Republic of
14		Kyunggi-Do		Korea, Republic of
15		Kyungju		Korea, Republic of
16		Kyungki		Korea, Republic of
17		Kyunki		Korea, Republic of
18		Pusan		Korea, Republic of
19		Seoul		Korea, Republic of
20		Ulsan		Korea, Republic of

Sponsors and Collaborators

• Janssen Korea, Ltd., Korea

Investigators

• Study Director: Janssen Korea, Ltd., Korea Clinical Trial, Janssen Korea, Ltd., Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen Korea, Ltd., Korea
• ClinicalTrials.gov Identifier: NCT00761189
• Other Study ID Numbers: CR015079; PAL-KOR-4001
• First Posted: Sep 29, 2008
• Last Update Posted: Mar 5, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Janssen Korea, Ltd., Korea: Paliperidone; R076477; Schizophrenia
• Additional relevant MeSH terms: Schizophrenia; Paliperidone Palmitate

Study Results

Participant Flow

Arm/Group Title	Paliperidone
Arm/Group Description	Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Period Title: Overall Study
STARTED	491
COMPLETED	306
NOT COMPLETED	185

Baseline Characteristics

Arm/Group Title	Paliperidone
Arm/Group Description	Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Overall Participants	491
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.7 (10.44)
Sex: Female, Male (Count of Participants)
Female	247 50.3%
Male	244 49.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
Description	The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.

Arm/Group Title	Paliperidone Extended-release (ER)
Arm/Group Description	Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Measure Participants	345
Number [Percentage of participants]	34.78 7.1%

2. Primary Outcome

Title	Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population
Description	The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.

Arm/Group Title	Paliperidone Extended-release (ER)
Arm/Group Description	Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Measure Participants	260
Number [Percentage of participants]	41.92 8.5%

3. Secondary Outcome

Title	Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population
Description	The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.
Time Frame	Baseline, Week 4 and 12

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.

Arm/Group Title	Paliperidone Extended-release (ER)
Arm/Group Description	Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Measure Participants	345
Baseline	49.39 (14.69)
Week 4	59.44 (13.54)
Week 12	62.76 (13.93)

4. Secondary Outcome

Title	Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population
Description	The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.
Time Frame	Baseline, Week 4 and Week 12

Outcome Measure Data

Analysis Population Description

Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.

Arm/Group Title	Paliperidone Extended-release (ER)
Arm/Group Description	Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Measure Participants	260
Baseline	49.70 (14.73)
Week 4	60.27 (13.34)
Week 12	64.73 (13.09)

5. Secondary Outcome

Title	Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population
Description	Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until Week 12 are reported here.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.

Arm/Group Title	Paliperidone Extended-release (ER)
Arm/Group Description	Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Measure Participants	345
Number [Percentage of participants]	38.84 7.9%

6. Secondary Outcome

Title	Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population
Description	Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until week 12 are reported here.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.

Arm/Group Title	Paliperidone Extended-release (ER)
Arm/Group Description	Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Measure Participants	260
Number [Percentage of Participants]	41.54 8.5%

7. Secondary Outcome

Title	Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population
Description	The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
Time Frame	Baseline, Week 4 and 12

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments. "N" (number of participants analyzed) signifies the participants evaluable for this measure.

Arm/Group Title	Paliperidone Extended-release (ER)
Arm/Group Description	Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Measure Participants	343
Baseline	-2.34 (4.78)
Week 4	-3.37 (4.53)
Week 12	-3.57 (4.54)

8. Secondary Outcome

Title	Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population
Description	The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
Time Frame	Baseline, Week 4 and 12

Outcome Measure Data

Analysis Population Description

Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. "N" (number of participants analyzed) signifies the participants evaluable for this measure.

Arm/Group Title	Paliperidone Extended-release (ER)
Arm/Group Description	Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Measure Participants	259
Baseline	-2.39 (4.81)
Week 4	-3.49 (4.53)
Week 12	-4.02 (4.26)

9. Secondary Outcome

Title	Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population
Description	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.
Time Frame	Baseline, Week 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.

Arm/Group Title	Paliperidone Extended-release (ER)
Arm/Group Description	Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Measure Participants	345
Baseline	4.62 (0.70)
Week 2	4.08 (0.81)
Week 4	3.73 (0.87)
Week 8	3.50 (0.91)
Week 12	3.29 (0.98)

10. Secondary Outcome

Title	Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population
Description	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.
Time Frame	Baseline, Week 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.

Arm/Group Title	Paliperidone Extended-release (ER)
Arm/Group Description	Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Measure Participants	260
Baseline	4.60 (0.68)
Week 2	4.02 (0.81)
Week 4	3.66 (0.85)
Week 8	3.40 (0.87)
Week 12	3.10 (0.91)

11. Secondary Outcome

Title	Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
Description	The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.

Arm/Group Title	Paliperidone Extended-release (ER)
Arm/Group Description	Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Measure Participants	345
Very much improved	5 1%
Much improved	115 23.4%
Minimally Improved	158 32.2%
No change	46 9.4%
Minimally worse	15 3.1%
Much worse	6 1.2%
Very much worse	0 0%

12. Secondary Outcome

Title	Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population
Description	The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. "N" (number of participants analyzed) signifies the participants evaluable for this measure.

Arm/Group Title	Paliperidone Extended-release (ER)
Arm/Group Description	Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
Measure Participants	260
Very much improved	5 1%
Much improved	104 21.2%
Minimally Improved	118 24%
No change	28 5.7%
Minimally worse	5 1%
Much worse	0 0%
Very much worse	0 0%

Adverse Events

Time Frame	Baseline up to Week 12
Adverse Event Reporting Description	Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
Arm/Group Title	Paliperidone
Arm/Group Description	Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
All Cause Mortality
	Paliperidone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Paliperidone
	Affected / at Risk (%)	# Events
Total	55/491 (11.2%)
Blood and lymphatic system disorders
Anaemia	1/491 (0.2%)
Gastrointestinal disorders
Gastric Ulcer	1/491 (0.2%)
Nausea	1/491 (0.2%)
Vomiting	1/491 (0.2%)
General disorders
Chest Discomfort	1/491 (0.2%)
Hepatobiliary disorders
Hepatic Steatosis	1/491 (0.2%)
Hepatotoxicity	1/491 (0.2%)
Injury, poisoning and procedural complications
Accidental Overdose	1/491 (0.2%)
Fall	1/491 (0.2%)
Lower Limb Fracture	1/491 (0.2%)
Tendon Injury	1/491 (0.2%)
Musculoskeletal and connective tissue disorders
Rhabdomyolysis	1/491 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Breast Neoplasm	1/491 (0.2%)
Nervous system disorders
Dizziness	1/491 (0.2%)
Dystonia	1/491 (0.2%)
Headache	2/491 (0.4%)
Tardive Dyskinesia	1/491 (0.2%)
Psychiatric disorders
Abnormal Behaviour	1/491 (0.2%)
Acute Psychosis	1/491 (0.2%)
Aggression	5/491 (1%)
Agitation	1/491 (0.2%)
Alcohol Abuse	1/491 (0.2%)
Anxiety	4/491 (0.8%)
Completed Suicide	1/491 (0.2%)
Delusion	3/491 (0.6%)
Hallucination	1/491 (0.2%)
Hallucination, Auditory	3/491 (0.6%)
Insomnia	1/491 (0.2%)
Nicotine Dependence	1/491 (0.2%)
Obsessive Thoughts	1/491 (0.2%)
Obsessive-Compulsive Disorder	1/491 (0.2%)
Psychotic Disorder	2/491 (0.4%)
Schizophrenia	13/491 (2.6%)
Schizophrenia, Paranoid Type	1/491 (0.2%)
Social Avoidant Behaviour	3/491 (0.6%)
Suicidal Ideation	1/491 (0.2%)
Suicide Attempt	1/491 (0.2%)
Social circumstances
Treatment Noncompliance	1/491 (0.2%)
Other (Not Including Serious) Adverse Events
	Paliperidone
	Affected / at Risk (%)	# Events
Total	243/491 (49.5%)
Gastrointestinal disorders
Constipation	46/491 (9.4%)
Dry Mouth	49/491 (10%)
Infections and infestations
Nasopharyngitis	10/491 (2%)
Musculoskeletal and connective tissue disorders
Muscle Rigidity	30/491 (6.1%)
Nervous system disorders
Akathisia	65/491 (13.2%)
Dizziness	13/491 (2.6%)
Dizziness Postural	24/491 (4.9%)
Headache	45/491 (9.2%)
Sedation	42/491 (8.6%)
Somnolence	42/491 (8.6%)
Tremor	35/491 (7.1%)
Psychiatric disorders
Insomnia	97/491 (19.8%)
Reproductive system and breast disorders
Amenorrhoea	21/491 (4.3%)

Limitations/Caveats

Some Adverse Events summaries were reported based on estimates due to the fact that they were not prepared in the original study report and the relevant definitions of the data elements were not available for these summaries to be regenerated.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

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. The sponsor cannot require changes to the communication and cannot extend the embargo.