Power: Efficacy Study of Paliperidone to Evaluate Subjective Change in Well-being and Drug Attitude in Schizophrenic Participants

• Sponsor: Janssen Korea, Ltd., Korea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00784238
• Collaborator: (none)
• Enrollment: 289
• Locations: 12
• Arm: 1
• Duration (Months): 33
• Patients Per Site: 24.1
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate improvement and efficacy of paliperidone extended-release for subjective well-being and drug attitudes of participants, when switching from oral antipsychotics 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), and non-comparative study, in participants with schizophrenia. The study consists of following parts: Screening (that is, 14 days before study commences on Day 1); Acute Treatment phase (24 weeks); Extension phase 1 (24 weeks), which will be followed by additional Extension phase 2 (48 weeks). Total study duration per participant will be 96 weeks. Efficacy will primarily be evaluated by change from Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale score and change from Baseline in Drug Attitude Inventory scores. Participants' safety will be monitored throughout the study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 289 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 Subjective Well-Being and Responses in Patients With Schizophrenia Who Had Switched to Paliperidone Extended-Release Tablets
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paliperidone Paliperidone Extended-Release (ER) oral tablet will be administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range will be 3 to 12 mg per day.	Drug: Paliperidone; Paliperidone ER oral tablet will be administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range will be 3 to 12 mg per day.; Other Names: R076477 Invega Extended-release tablet

Outcome Measures

Primary Outcome Measures

1. Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at Week 24 [Week 24]

   The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.

2. Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24 [Baseline and Week 24]

   The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.

3. Change From Baseline in Mental Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24 [Baseline and Week 24]

   The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Mental functioning subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.

4. Change From Baseline in Self-Control Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24 [Baseline and Week 24]

   The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Self-Control subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.

5. Change From Baseline in Emotional Regulation Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24 [Baseline and Week 24]

   The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Emotional Regulation subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.

6. Change From Baseline in Physical Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24 [Baseline and Week 24]

   The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Physical Functioning subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.

7. Change From Baseline in Social Integration Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24 [Baseline and Week 24]

   The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Social integration subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.

8. Drug Attitude Inventory (DAI-10) Total Score at Week 24 [Week 24]

   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).

9. Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 24 [Baseline and Week 24]

   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). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.

Secondary Outcome Measures

1. Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24 [Baseline and Week 24]

   The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.

2. Change From Baseline in Krawiecka Scale Score at Week 24 [Baseline and Week 24]

   Psychopathology of participants was assessed by Krawiecka scale. Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16. Higher score indicates worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.

3. Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24 [Baseline and Week 24]

   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. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.

4. Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24 [Baseline and Week 24]

   Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: "very badly" to 100: "very well"). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.

5. Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24 [Baseline and Week 24]

   Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: "very badly" to 100: "very well"). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Participants who are diagnosed with schizophrenia (diagnosis criteria: Diagnostic and Statistical Manual of Mental Disorders, fourth edition [DSM-IV])

• Participants who need to change the antipsychotic drug to another one for the following reasons among the participants treated with an antipsychotic drug for more than two weeks before the screening-Lack of efficacy, lack of tolerance or lack of compliance

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

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

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

Exclusion Criteria:

• Participants with the past history of neuroleptic malignant syndrome (NMS), or with allergy or hypersensitivity to risperidone or paliperidone

• Participants who have taken clozapine within one month before screening

• Participants who are suspicious of having clinically significant risk including suicide or aggressive behavior and are expected to unable to complete the study (based on the investigator's judgment)

• Participants with severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or participants who cannot 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 with a known or suspected history (for 6 months and longer) of substance dependence according to the DSM-IV criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Busan		Korea, Republic of
2		Changnyeong-Gun		Korea, Republic of
3		Chonju		Korea, Republic of
4		Chun-An		Korea, Republic of
5		Chungcheongbuk-Do		Korea, Republic of
6		Dae-Jeon		Korea, Republic of
7		Daegu		Korea, Republic of
8		Daejeon		Korea, Republic of
9		Hwasun Gun		Korea, Republic of
10		Iksan		Korea, Republic of
11		Kwangjoo		Korea, Republic of
12		Naju		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: NCT00784238
• Other Study ID Numbers: CR015391; R076477SCH4028
• First Posted: Nov 2, 2008
• Last Update Posted: Mar 27, 2014
• Last Verified: Feb 1, 2014

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

Study Results

Participant Flow

Arm/Group Title	Paliperidone
Arm/Group Description	Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
Period Title: Overall Study
STARTED	289
COMPLETED	170
NOT COMPLETED	119

Baseline Characteristics

Arm/Group Title	Paliperidone
Arm/Group Description	Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
Overall Participants	289
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.4 (10.09)
Sex: Female, Male (Count of Participants)
Female	153 52.9%
Male	136 47.1%

Outcome Measures

1. Primary Outcome

Title	Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at Week 24
Description	The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.

Arm/Group Title	Paliperidone
Arm/Group Description	Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
Measure Participants	284
Mean (Standard Deviation) [Units on a scale]	77.89 (17.95)

2. Primary Outcome

Title	Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Description	The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.

Arm/Group Title	Paliperidone (Lack of Efficacy Group)	Paliperidone (Lack of Tolerability Group)	Paliperidone (Lack of Compliance Group)
Arm/Group Description	Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Measure Participants	179	47	58
Baseline	74.59 (17.81)	76.51 (17.61)	81.19 (15.68)
Change at Week 24	-1.59 (13.75)	-2.66 (13.72)	-0.93 (16.93)

3. Primary Outcome

Title	Change From Baseline in Mental Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Description	The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Mental functioning subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.

Arm/Group Title	Paliperidone (Lack of Efficacy Group)	Paliperidone (Lack of Tolerability Group)	Paliperidone (Lack of Compliance Group)
Arm/Group Description	Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Measure Participants	179	47	58
Mean (Standard Deviation) [Units on a scale]	-0.14 (3.56)	-0.51 (3.62)	-0.24 (4.79)

4. Primary Outcome

Title	Change From Baseline in Self-Control Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Description	The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Self-Control subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.

Arm/Group Title	Paliperidone (Lack of Efficacy Group)	Paliperidone (Lack of Tolerability Group)	Paliperidone (Lack of Compliance Group)
Arm/Group Description	Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Measure Participants	179	47	58
Mean (Standard Deviation) [Units on a scale]	-0.72 (3.74)	-0.62 (4.05)	-0.29 (4.07)

5. Primary Outcome

Title	Change From Baseline in Emotional Regulation Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Description	The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Emotional Regulation subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.

Arm/Group Title	Paliperidone (Lack of Efficacy Group)	Paliperidone (Lack of Tolerability Group)	Paliperidone (Lack of Compliance Group)
Arm/Group Description	Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Measure Participants	179	47	58
Mean (Standard Deviation) [Units on a scale]	-0.07 (3.61)	0.11 (4.07)	0.45 (3.97)

6. Primary Outcome

Title	Change From Baseline in Physical Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Description	The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Physical Functioning subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.

Arm/Group Title	Paliperidone (Lack of Efficacy Group)	Paliperidone (Lack of Tolerability Group)	Paliperidone (Lack of Compliance Group)
Arm/Group Description	Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Measure Participants	179	47	58
Mean (Standard Deviation) [Units on a scale]	-0.11 (4.15)	-0.68 (4.25)	0.47 (4.50)

7. Primary Outcome

Title	Change From Baseline in Social Integration Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Description	The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Social integration subscale score ranges from 0 to 24 and higher score indicates improvement of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.

Arm/Group Title	Paliperidone (Lack of Efficacy Group)	Paliperidone (Lack of Tolerability Group)	Paliperidone (Lack of Compliance Group)
Arm/Group Description	Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Measure Participants	179	47	58
Mean (Standard Deviation) [Units on a scale]	-0.55 (3.33)	-0.96 (3.26)	-1.31 (4.04)

8. Primary Outcome

Title	Drug Attitude Inventory (DAI-10) Total Score at Week 24
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	Week 24

Outcome Measure Data

Analysis Population Description

The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.

Arm/Group Title	Paliperidone
Arm/Group Description	Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
Measure Participants	284
Mean (Standard Deviation) [Units on a scale]	3.58 (4.73)

9. Primary Outcome

Title	Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 24
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). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.

Arm/Group Title	Paliperidone (Lack of Efficacy Group)	Paliperidone (Lack of Tolerability Group)	Paliperidone (Lack of Compliance Group)
Arm/Group Description	Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Measure Participants	179	47	58
Baseline	3.12 (4.65)	3.49 (4.67)	2.50 (4.88)
Change at Week 24	-0.46 (4.70)	-0.21 (4.92)	-1.00 (5.03)

10. Secondary Outcome

Title	Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24
Description	The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies the participants evaluable for this measure.

Arm/Group Title	Paliperidone (Lack of Efficacy Group)	Paliperidone (Lack of Tolerability Group)	Paliperidone (Lack of Compliance Group)
Arm/Group Description	Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Measure Participants	179	47	57
Baseline	109.65 (67.00)	107.23 (72.17)	83.39 (60.41)
Change at Week 24	2.42 (30.44)	9.40 (32.31)	1.16 (17.83)

11. Secondary Outcome

Title	Change From Baseline in Krawiecka Scale Score at Week 24
Description	Psychopathology of participants was assessed by Krawiecka scale. Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16. Higher score indicates worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.

Arm/Group Title	Paliperidone (Lack of Efficacy Group)	Paliperidone (Lack of Tolerability Group)	Paliperidone (Lack of Compliance Group)
Arm/Group Description	Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Measure Participants	179	47	58
Baseline	4.78 (3.12)	3.45 (2.82)	3.86 (2.96)
Change at Week 24	0.94 (2.90)	1.09 (2.80)	1.09 (3.00)

12. Secondary Outcome

Title	Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24
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. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.

Arm/Group Title	Paliperidone (Lack of Efficacy Group)	Paliperidone (Lack of Tolerability Group)	Paliperidone (Lack of Compliance Group)
Arm/Group Description	Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Measure Participants	179	47	58
Baseline	52.15 (15.44)	57.91 (16.31)	58.71 (12.62)
Change at Week 24	-6.50 (14.36)	-7.23 (12.49)	-6.28 (10.70)

13. Secondary Outcome

Title	Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24
Description	Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: "very badly" to 100: "very well"). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.

Arm/Group Title	Paliperidone (Lack of Efficacy Group)	Paliperidone (Lack of Tolerability Group)	Paliperidone (Lack of Compliance Group)
Arm/Group Description	Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Measure Participants	179	47	58
Baseline	61.84 (29.34)	71.55 (24.92)	69.31 (23.48)
Change at Week 24	-0.84 (31.22)	-0.43 (30.25)	-0.67 (22.42)

14. Secondary Outcome

Title	Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24
Description	Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: "very badly" to 100: "very well"). Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.

Arm/Group Title	Paliperidone (Lack of Efficacy Group)	Paliperidone (Lack of Tolerability Group)	Paliperidone (Lack of Compliance Group)
Arm/Group Description	Paliperidone ER tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).	Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
Measure Participants	179	47	58
Baseline	40.57 (31.79)	45.96 (31.18)	46.55 (28.65)
Change at Week 24	-1.18 (32.17)	3.94 (28.02)	10.05 (25.75)

Adverse Events

Time Frame	Baseline up to Week 96
Adverse Event Reporting Description	Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Arm/Group Title	Paliperidone
Arm/Group Description	Paliperidone Extended-Release (ER) oral tablet was administered once daily at a starting dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
All Cause Mortality
	Paliperidone
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Paliperidone
	Affected / at Risk (%)	# Events
Total	21/289 (7.3%)
General disorders
Condition Aggravated	1/289 (0.3%)
Injury, poisoning and procedural complications
Ankle Fracture	1/289 (0.3%)
Road Traffic Accident	1/289 (0.3%)
Investigations
Hepatic Enzyme Increased	1/289 (0.3%)
Musculoskeletal and connective tissue disorders
Muscle Rigidity	1/289 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma	1/289 (0.3%)
Nervous system disorders
Dizziness	1/289 (0.3%)
Dystonia	1/289 (0.3%)
Pregnancy, puerperium and perinatal conditions
Ectopic Pregnancy	1/289 (0.3%)
Psychiatric disorders
Acute Psychosis	1/289 (0.3%)
Completed Suicide	2/289 (0.7%)
Delusion	1/289 (0.3%)
Hallucination, Auditory	3/289 (1%)
Insomnia	1/289 (0.3%)
Psychotic Behaviour	2/289 (0.7%)
Psychotic Disorder	1/289 (0.3%)
Schizophrenia	4/289 (1.4%)
Schizophrenia, Paranoid Type	1/289 (0.3%)
Social Avoidant Behaviour	1/289 (0.3%)
Suicidal Ideation	1/289 (0.3%)
Other (Not Including Serious) Adverse Events
	Paliperidone
	Affected / at Risk (%)	# Events
Total	112/289 (38.8%)
Gastrointestinal disorders
Constipation	11/289 (3.8%)
Dry Mouth	8/289 (2.8%)
Dyspepsia	7/289 (2.4%)
Nausea	8/289 (2.8%)
Investigations
Weight Increased	6/289 (2.1%)
Musculoskeletal and connective tissue disorders
Muscle Rigidity	7/289 (2.4%)
Nervous system disorders
Akathisia	24/289 (8.3%)
Bradykinesia	12/289 (4.2%)
Dizziness	11/289 (3.8%)
Dystonia	9/289 (3.1%)
Essential Tremor	6/289 (2.1%)
Extrapyramidal Disorder	14/289 (4.8%)
Headache	10/289 (3.5%)
Sedation	6/289 (2.1%)
Somnolence	7/289 (2.4%)
Tremor	14/289 (4.8%)
Psychiatric disorders
Insomnia	14/289 (4.8%)

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

Principal Investigators are NOT 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.