## Protocol Section
### Identification Module
**NCT ID:** NCT00604279

**Brief Title:** A Comparative Study of Paliperidone Palmitate and Risperidone Long Acting Injection (LAI) in Participants With Schizophrenia

**Official Title:** A Randomized, Open-Label, Parallel Group Comparative Study of Paliperidone Palmitate (50, 100, 150 mg eq) and Risperidone LAI (25, 37.5, or 50 mg) in Subjects With Schizophrenia

#### Organization Study ID Info
**ID:** CR013150
#### Organization
**Class:** INDUSTRY
**Full Name:** Xian-Janssen Pharmaceutical Ltd.
#### Secondary ID Infos
**ID:** R092670PSY3008
### Status Module
#### Completion Date
**Date:** 2009-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-07-10

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-06-04

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-01

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2013-07-10

**Type:** ESTIMATED

**Results First Submit Date:** 2013-02-21

**Results First Submit QC Date:** 2013-06-04

#### Start Date
**Date:** 2008-01

**Status Verified Date:** 2013-06

#### Study First Post Date
**Date:** 2008-01-30
**Type:** ESTIMATED
**Study First Submit Date:** 2008-01-17
**Study First Submit QC Date:** 2008-01-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Xian-Janssen Pharmaceutical Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to compare the efficacy of paliperidone palmitate and risperidone long acting injection (LAI) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) along with safety and tolerability.

**Detailed Description:** This is a randomized (assigned by chance), open-label (all people know the identity of the intervention), active-controlled, parallel-group (a medical research study comparing the response in two or more groups of participants receiving different treatments), multicenter (when more than one hospital or medical school team work on a medical research study) comparative study in participants with schizophrenia. This study comprises a screening period of not more than 7 days and a 13-week open-label treatment period. Paliperidone palmitate will be administered as intramuscular injection (injection of a substance into a muscle) of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. at Day 8, flexible dose on Day 36 (50 or 100 mg eq.) and on Day 64 (50, 100 or 150 mg eq.) depending on investigator's discretion. Risperidone LAI will be administered at a dose of 25 mg at Day 8 and Day 22, flexible dose on Day 36 (25 or 37.5 mg) and Day 64 (25, 37.5, or 50 mg). Dose on Day 50 is the same as Day 36 and dose on Day 78 is the same as Day 64. Participants will receive oral risperidone tablets (1 to 6 mg/day) for the first 4 weeks of the open-label treatment period. Each participant may receive oral risperidone tablets (1 to 2 mg daily) for up to 3 weeks at Day 36 and Day 64 if the dose of risperidone LAI was increased on Day 36 and Day 64. Efficacy will primarily be assessed using the Positive and Negative Syndrome Scale (PANSS). Participants' safety will also be assessed.

### Conditions Module

**Conditions:**

- Schizophrenia

**Keywords:**

- Schizophrenia

- Paliperidone

- Paliperidone palmitate

- Risperidone

- Risperidone long acting injection

- R092670

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 452

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion.

**Intervention Names:**

- Drug: Paliperidone palmitate (R092670)

**Label:** Paliperidone palmitate

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.

**Intervention Names:**

- Drug: Risperidone

**Label:** Risperidone long acting injection (LAI)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Paliperidone palmitate

**Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq.on Day 64 depending on investigator's discretion.

**Name:** Paliperidone palmitate (R092670)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Risperidone long acting injection (LAI)

**Description:** Risperidone LAI intramuscular at a dose of 25 mg on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.

**Name:** Risperidone

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme psychopathology). Higher change scores indicate worsening.

**Measure:** Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal

**Time Frame:** Baseline, Day 92 or early withdrawal

#### Secondary Outcomes

**Description:** This PSP assesses the degree of a participant's 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 4, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; \<= 30, functioning so poorly as to require intensive supervision.

**Measure:** Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal

**Time Frame:** Baseline, Day 92 or early withdrawal

**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 change scores indicate worsening.

**Measure:** Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal

**Time Frame:** Baseline, Day 92 or early withdrawal

**Description:** The self-administered sleep VAS scale (0-100 millimeter \[mm\]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).

**Measure:** Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal

**Time Frame:** Baseline, Day 92 or early withdrawal

**Description:** A responder is defined as a participant who improved from baseline in the PANSS total score by 30 percent or more.

**Measure:** Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal

**Time Frame:** Day 92 or early withdrawal

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participants who meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (disorganized type \[295.10\], catatonic type \[295.20\], paranoid type \[295.30\], residual type \[295.60\], or undifferentiated type \[295.90\]) for at least 1 year before screening and prior medical records, written documentation, or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
* A total Positive and Negative Syndrome Scale (PANSS) score between 60 and 120, inclusive, at screening and baseline
* Body mass index (BMI) of equal to or greater than 17.0 kilogram per meter square (kg/m\^2)
* Female participants must be postmenopausal for at least 2 years, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before study entry and throughout the study
* Be capable of self-administering study medication (applies to oral supplementation) or have assistance with study medication administration consistently available throughout the first 4 weeks of the study Exclusion Criteria:
* A primary, active DSM-IV diagnosis on Axis I other than schizophrenia
* A decrease of at least 25 percent in the total PANSS score between screening and baseline
* Participants who have previously participated in this study
* A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
* History of treatment resistance as defined by failure to respond to 2 adequate treatments with different antipsychotic medications (an adequate treatment is defined as a minimum of 6 weeks at maximum tolerated dosage)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Baoding

**Country:** China

**Location 2:**

**City:** Beijing

**Country:** China

**Location 3:**

**City:** Guangzhou

**Country:** China

**Location 4:**

**City:** Hangzhou

**Country:** China

**Location 5:**

**City:** Nanjing

**Country:** China

**Location 6:**

**City:** Shanghai

**Country:** China

**Location 7:**

**City:** Wuhan

**Country:** China

**Location 8:**

**City:** Xian

**Country:** China

#### Overall Officials

**Official 1:**

**Affiliation:** Xian-Janssen Pharmaceutical Ltd.

**Name:** Xian-Janssen Pharmaceutical Ltd. Clinical Trial

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019967

- Term: Schizophrenia Spectrum and Other Psychotic Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M15376

- Name: Schizophrenia

- Relevance: HIGH

- As Found: Schizophrenia

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21838

- Name: Schizophrenia Spectrum and Other Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012559

- Term: Schizophrenia

### Intervention Browse Module - Ancestors

- ID: D000012702

- Term: Serotonin Antagonists

- ID: D000018490

- Term: Serotonin Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000014150

- Term: Antipsychotic Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000018492

- Term: Dopamine Antagonists

- ID: D000015259

- Term: Dopamine Agents

- ID: D000058830

- Term: Serotonin 5-HT2 Receptor Antagonists

- ID: D000065127

- Term: Dopamine D2 Receptor Antagonists

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CaAg

- Name: Cardiotonic Agents

### Intervention Browse Module - Browse Leaves

- ID: M20999

- Name: Risperidone

- Relevance: HIGH

- As Found: Evening

- ID: M329

- Name: Paliperidone Palmitate

- Relevance: HIGH

- As Found: Canadian

- ID: M15512

- Name: Serotonin

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M16904

- Name: Antipsychotic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M7473

- Name: Dopamine

- Relevance: LOW

- As Found: Unknown

- ID: M20596

- Name: Dopamine Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M17962

- Name: Dopamine Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000018967

- Term: Risperidone

- ID: D000068882

- Term: Paliperidone Palmitate

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Paliperidone Palmitate

**Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.

**ID:** EG000

**Other Num Affected:** 115

**Other Num at Risk:** 229

**Serious Number Affected:** 3

**Serious Number At Risk:** 229

**Title:** Paliperidone Palmitate

**Group ID:** EG001

**Title:** Risperidone Long Acting Injection (LAI)

**Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.

**ID:** EG001

**Other Num Affected:** 127

**Other Num at Risk:** 223

**Serious Number Affected:** 8

**Serious Number At Risk:** 223

**Title:** Risperidone Long Acting Injection (LAI)

**Frequency Threshold:** 5

#### Other Events

**Term:** Constipation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 12.0

**Term:** Upper respiratory tract infection

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 12.0

**Term:** Blood prolactin increased

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA Version 12.0

**Term:** Musculoskeletal stiffness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA Version 12.0

**Term:** Akathisia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 12.0

**Term:** Bradykinesia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 12.0

**Term:** Tremor

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 12.0

**Term:** Anxiety

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA Version 12.0

**Term:** Insomnia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA Version 12.0

**Term:** Restlessness

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA Version 12.0

#### Serious Events

**Term:** Nausea

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 12.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 229

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 223

**Term:** Vomiting

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA Version 12.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 229

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 223

**Term:** Lumbar vertebral fracture

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 12.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 229

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 223

**Term:** Overdose

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 12.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 229

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 223

**Term:** Road traffic accident

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 12.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 229

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 223

**Term:** Cerebral infarction

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 12.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 229

**Group ID:** EG001

**Num At Risk:** 223

**Term:** Convulsion

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 12.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 229

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 223

**Term:** Completed suicide

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA Version 12.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 229

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 223

**Term:** Psychiatric symptom

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA Version 12.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 229

**Group ID:** EG001

**Num At Risk:** 223

**Term:** Schizophrenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA Version 12.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 229

**Group ID:** EG001

**Num At Risk:** 223

**Term:** Hydronephrosis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA Version 12.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 229

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 223

**Term:** Nephrolithiasis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA Version 12.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 229

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 223

**Term:** Refusal of treatment by patient

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Social circumstances

**Source Vocabulary:** MedDRA Version 12.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 229

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 223

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 229

**Group ID:** BG001

**Value:** 223

**Group ID:** BG002

**Value:** 452

**Units:** Participants

### Group

**ID:** BG000

**Title:** Paliperidone Palmitate

**Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.

### Group

**ID:** BG001

**Title:** Risperidone Long Acting Injection (LAI)

**Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.75

**Value:** 32

#### Measurement

**Group ID:** BG001

**Spread:** 11.03

**Value:** 31.5

#### Measurement

**Group ID:** BG002

**Spread:** 10.88

**Value:** 31.7

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 142

#### Measurement

**Group ID:** BG001

**Value:** 129

#### Measurement

**Group ID:** BG002

**Value:** 271

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 87

#### Measurement

**Group ID:** BG001

**Value:** 94

#### Measurement

**Group ID:** BG002

**Value:** 181

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 87

#### Measurement

**Group ID:** BG001

**Value:** 92

#### Measurement

**Group ID:** BG002

**Value:** 179

**Class Title:** 18-25 Years

#### Measurement

**Group ID:** BG000

**Value:** 125

#### Measurement

**Group ID:** BG001

**Value:** 114

#### Measurement

**Group ID:** BG002

**Value:** 239

**Class Title:** 26-50 Years

#### Measurement

**Group ID:** BG000

**Value:** 17

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 34

**Class Title:** 51-65 Years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Class Title:** >65 Years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Class Title:** <18 Years

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Age Categorical
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** The disclosure restriction on the PI is that the sponsor can review results communications prior to publication 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 paper that incorporates confidential information requires Sponsor's written consent. PI will withhold publication for up to an additional 60 days to allow for filing of a patent application.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Organization:** Xian-Janssen Pharmaceutical Ltd
**Phone:** 86-10-5821 8213
**Title:** Local Trial Manager
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -5.20
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 0.63
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 1.48
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** The predetermined margin for non-inferiority of paliperidone palmitate was 5.5 points
**Non-Inferiority Type:** NON_INFERIORITY_OR_EQUIVALENCE
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Least Square Mean Difference
**Parameter Value:** -2.3
**Statistical Comment:** Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** True
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** -2.14
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 3.12
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 1.34
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Least Square Mean Difference
**Parameter Value:** 0.5
**Statistical Comment:** Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** -0.33
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 0.10
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 0.11
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Least Square Mean Difference
**Parameter Value:** -0.1
**Statistical Comment:** Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** -0.67
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 7.50
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 2.08
**Estimate Comment:** 
**Group Description:** Statistical Analysis for Quality of sleep
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Least Square Mean Difference
**Parameter Value:** 3.4
**Statistical Comment:** Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
#### Analysis
**CI Lower Limit:** -5.04
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 2.90
**CI Upper Limit Comment:** 
**Dispersion Type:** STANDARD_ERROR_OF_MEAN
**Dispersion Value:** 2.02
**Estimate Comment:** 
**Group Description:** Statistical Analysis for Daytime drowsiness
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Least Square Mean Difference
**Parameter Value:** -1.1
**Statistical Comment:** Analysis of covariance (ANCOVA) model with treatment as a factor, and baseline value as a covariate was used.
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** False
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 0.81
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** 1.01
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Point estimate of relative risk
**Parameter Value:** 0.9
**Statistical Comment:** 
**Statistical Method:** Cochran-Mantel-Haenszel
**Tested Non-Inferiority:** False
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 11.95
- **Upper Limit:** 
- **Value:** 82.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 12.69
- **Upper Limit:** 
- **Value:** 84.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 16.28
- **Upper Limit:** 
- **Value:** -23.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 15.43
- **Upper Limit:** 
- **Value:** -26.9
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 12.42
- **Upper Limit:** 
- **Value:** 47.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 11.29
- **Upper Limit:** 
- **Value:** 45.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 14.76
- **Upper Limit:** 
- **Value:** 16.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13.92
- **Upper Limit:** 
- **Value:** 18.6
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.82
- **Upper Limit:** 
- **Value:** 4.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.81
- **Upper Limit:** 
- **Value:** 5.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.24
- **Upper Limit:** 
- **Value:** -1.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1.16
- **Upper Limit:** 
- **Value:** -1.7
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 25.40
- **Upper Limit:** 
- **Value:** 64.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 24.22
- **Upper Limit:** 
- **Value:** 66.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 26.95
- **Upper Limit:** 
- **Value:** 8.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 26.18
- **Upper Limit:** 
- **Value:** 10.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 25.25
- **Upper Limit:** 
- **Value:** 29.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 23.50
- **Upper Limit:** 
- **Value:** 29.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 27.26
- **Upper Limit:** 
- **Value:** -4.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 24.12
- **Upper Limit:** 
- **Value:** -4.9
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 25.40
- **Upper Limit:** 
- **Value:** 70.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 24.22
- **Upper Limit:** 
- **Value:** 78.4
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 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 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme psychopathology). Higher change scores indicate worsening.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Per Protocol Analysis Set included participants who received at least 2 injections of study medication had minimum 5 weeks of exposure to study treatment; had baseline and at least 1 post randomization measurement for primary efficacy variable and who did not have major protocol violations.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Day 92 or early withdrawal
**Title:** Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 92 or Early Withdrawal
**Type:** PRIMARY
**Unit of Measure:** Units on scale
##### Group
**Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
**ID:** OG000
**Title:** Paliperidone Palmitate
##### Group
**Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
**ID:** OG001
**Title:** Risperidone Long Acting Injection (LAI)
#### Outcome Measure 2
**Description:** This PSP assesses the degree of a participant's 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 4, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; \<= 30, functioning so poorly as to require intensive supervision.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Per Protocol Analysis Set. Here "N" (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Day 92 or early withdrawal
**Title:** Change From Baseline in Personal and Social Performance (PSP) Score at Day 92 or Early Withdrawal
**Type:** SECONDARY
**Unit of Measure:** Units on scale
##### Group
**Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
**ID:** OG000
**Title:** Paliperidone Palmitate
##### Group
**Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
**ID:** OG001
**Title:** Risperidone Long Acting Injection (LAI)
#### Outcome Measure 3
**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 change scores indicate worsening.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Per Protocol Analysis Set. Here "N" (Number of Participants Analyzed) represents number of participants who were evaluable for this measure.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Day 92 or early withdrawal
**Title:** Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Day 92 or Early Withdrawal
**Type:** SECONDARY
**Unit of Measure:** Units on scale
##### Group
**Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
**ID:** OG000
**Title:** Paliperidone Palmitate
##### Group
**Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
**ID:** OG001
**Title:** Risperidone Long Acting Injection (LAI)
#### Outcome Measure 4
**Description:** The self-administered sleep VAS scale (0-100 millimeter \[mm\]) rates quality of sleep (QoS) and daytime drowsiness (DD). Participants indicate mark on the scale to represent how well they have slept in the previous 7 days, score ranges from 0 mm (very badly) to 100 mm (very well); and how often they have felt drowsy within the previous 7 days, from 0 mm (not at all) to 100 mm (all the time).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Per Protocol Analysis Set.
**Reporting Status:** POSTED
**Time Frame:** Baseline, Day 92 or early withdrawal
**Title:** Change From Baseline in the Sleep Visual Analog Scale (VAS) Score at Day 92 or Early Withdrawal
**Type:** SECONDARY
**Unit of Measure:** millimeter (mm)
##### Group
**Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
**ID:** OG000
**Title:** Paliperidone Palmitate
##### Group
**Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
**ID:** OG001
**Title:** Risperidone Long Acting Injection (LAI)
#### Outcome Measure 5
**Description:** A responder is defined as a participant who improved from baseline in the PANSS total score by 30 percent or more.
**Parameter Type:** NUMBER
**Population Description:** Per Protocol Analysis Set.
**Reporting Status:** POSTED
**Time Frame:** Day 92 or early withdrawal
**Title:** Percentage of Participants Who Responded to PANSS Total Score at Day 92 or Early Withdrawal
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
**ID:** OG000
**Title:** Paliperidone Palmitate
##### Group
**Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
**ID:** OG001
**Title:** Risperidone Long Acting Injection (LAI)
### Participant Flow Module
#### Group
**Description:** Paliperidone palmitate (R092670) suspension for intramuscular (directly into a muscle) injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator's discretion.
**ID:** FG000
**Title:** Paliperidone Palmitate
#### Group
**Description:** Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
**ID:** FG001
**Title:** Risperidone Long Acting Injection (LAI)
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 22
###### Reason
**Group ID:** FG001
**Number of Subjects:** 9
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 9
###### Reason
**Group ID:** FG001
**Number of Subjects:** 14
##### Withdraw
**Type:** Pregnancy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 16
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 4
###### Reason
**Group ID:** FG001
**Number of Subjects:** 5
##### Withdraw
**Type:** Other
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 229
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 223
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 165
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 185
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 64
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 38
**Has Results:** True