Trial Outcomes & Findings for Efficacy Study of Paliperidone to Evaluate Subjective Change in Well-being and Drug Attitude in Schizophrenic Participants (NCT NCT00784238)

NCT ID: NCT00784238

Last Updated: 2014-03-27

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

289 participants

Primary outcome timeframe

Week 24

Results posted on

2014-03-27

Participant Flow

Participant milestones

Participant milestones
Measure	Paliperidone 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 Study STARTED	289
Overall Study COMPLETED	170
Overall Study NOT COMPLETED	119

Reasons for withdrawal

Reasons for withdrawal
Measure	Paliperidone 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 Study Adverse Event	14
Overall Study Death	2
Overall Study Lack of Efficacy	33
Overall Study Lost to Follow-up	29
Overall Study Pregnancy	1
Overall Study Withdrawal by Subject	26
Overall Study Other	14

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paliperidone n=289 Participants 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.
Age, Continuous	36.4 years STANDARD_DEVIATION 10.09 • n=5 Participants
Sex: Female, Male Female	153 Participants n=5 Participants
Sex: Female, Male Male	136 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: 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.

Outcome measures

Outcome measures
Measure	Paliperidone n=284 Participants 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.	Paliperidone (Lack of Tolerability Group) 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 (Lack of Compliance Group) 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).
Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at Week 24	77.89 Units on a scale Standard Deviation 17.95	—	—

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paliperidone n=179 Participants 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.	Paliperidone (Lack of Tolerability Group) n=47 Participants 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 (Lack of Compliance Group) n=58 Participants 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).
Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24 Baseline	74.59 Units on a scale Standard Deviation 17.81	76.51 Units on a scale Standard Deviation 17.61	81.19 Units on a scale Standard Deviation 15.68
Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24 Change at Week 24	-1.59 Units on a scale Standard Deviation 13.75	-2.66 Units on a scale Standard Deviation 13.72	-0.93 Units on a scale Standard Deviation 16.93

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paliperidone n=179 Participants 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.	Paliperidone (Lack of Tolerability Group) n=47 Participants 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 (Lack of Compliance Group) n=58 Participants 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).
Change From Baseline in Mental Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24	-0.14 Units on a scale Standard Deviation 3.56	-0.51 Units on a scale Standard Deviation 3.62	-0.24 Units on a scale Standard Deviation 4.79

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paliperidone n=179 Participants 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.	Paliperidone (Lack of Tolerability Group) n=47 Participants 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 (Lack of Compliance Group) n=58 Participants 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).
Change From Baseline in Self-Control Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24	-0.72 Units on a scale Standard Deviation 3.74	-0.62 Units on a scale Standard Deviation 4.05	-0.29 Units on a scale Standard Deviation 4.07

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paliperidone n=179 Participants 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.	Paliperidone (Lack of Tolerability Group) n=47 Participants 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 (Lack of Compliance Group) n=58 Participants 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).
Change From Baseline in Emotional Regulation Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24	-0.07 Units on a scale Standard Deviation 3.61	0.11 Units on a scale Standard Deviation 4.07	0.45 Units on a scale Standard Deviation 3.97

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paliperidone n=179 Participants 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.	Paliperidone (Lack of Tolerability Group) n=47 Participants 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 (Lack of Compliance Group) n=58 Participants 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).
Change From Baseline in Physical Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24	-0.11 Units on a scale Standard Deviation 4.15	-0.68 Units on a scale Standard Deviation 4.25	0.47 Units on a scale Standard Deviation 4.50

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paliperidone n=179 Participants 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.	Paliperidone (Lack of Tolerability Group) n=47 Participants 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 (Lack of Compliance Group) n=58 Participants 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).
Change From Baseline in Social Integration Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24	-0.55 Units on a scale Standard Deviation 3.33	-0.96 Units on a scale Standard Deviation 3.26	-1.31 Units on a scale Standard Deviation 4.04

PRIMARY outcome

Timeframe: Week 24

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Paliperidone n=284 Participants 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.	Paliperidone (Lack of Tolerability Group) 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 (Lack of Compliance Group) 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).
Drug Attitude Inventory (DAI-10) Total Score at Week 24	3.58 Units on a scale Standard Deviation 4.73	—	—

PRIMARY outcome

Timeframe: Baseline and Week 24

Population: 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.

Outcome measures

Outcome measures
Measure	Paliperidone n=179 Participants 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.	Paliperidone (Lack of Tolerability Group) n=47 Participants 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 (Lack of Compliance Group) n=58 Participants 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).
Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 24 Baseline	3.12 Units on a scale Standard Deviation 4.65	3.49 Units on a scale Standard Deviation 4.67	2.50 Units on a scale Standard Deviation 4.88
Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 24 Change at Week 24	-0.46 Units on a scale Standard Deviation 4.70	-0.21 Units on a scale Standard Deviation 4.92	-1.00 Units on a scale Standard Deviation 5.03

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paliperidone n=179 Participants 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.	Paliperidone (Lack of Tolerability Group) n=47 Participants 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 (Lack of Compliance Group) n=57 Participants 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).
Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24 Baseline	109.65 Units on a scale Standard Deviation 67.00	107.23 Units on a scale Standard Deviation 72.17	83.39 Units on a scale Standard Deviation 60.41
Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24 Change at Week 24	2.42 Units on a scale Standard Deviation 30.44	9.40 Units on a scale Standard Deviation 32.31	1.16 Units on a scale Standard Deviation 17.83

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paliperidone n=179 Participants 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.	Paliperidone (Lack of Tolerability Group) n=47 Participants 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 (Lack of Compliance Group) n=58 Participants 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).
Change From Baseline in Krawiecka Scale Score at Week 24 Baseline	4.78 Units on a scale Standard Deviation 3.12	3.45 Units on a scale Standard Deviation 2.82	3.86 Units on a scale Standard Deviation 2.96
Change From Baseline in Krawiecka Scale Score at Week 24 Change at Week 24	0.94 Units on a scale Standard Deviation 2.90	1.09 Units on a scale Standard Deviation 2.80	1.09 Units on a scale Standard Deviation 3.00

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paliperidone n=179 Participants 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.	Paliperidone (Lack of Tolerability Group) n=47 Participants 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 (Lack of Compliance Group) n=58 Participants 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).
Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24 Baseline	52.15 Units on a scale Standard Deviation 15.44	57.91 Units on a scale Standard Deviation 16.31	58.71 Units on a scale Standard Deviation 12.62
Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24 Change at Week 24	-6.50 Units on a scale Standard Deviation 14.36	-7.23 Units on a scale Standard Deviation 12.49	-6.28 Units on a scale Standard Deviation 10.70

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paliperidone n=179 Participants 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.	Paliperidone (Lack of Tolerability Group) n=47 Participants 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 (Lack of Compliance Group) n=58 Participants 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).
Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24 Baseline	61.84 Millimeter (mm) Standard Deviation 29.34	71.55 Millimeter (mm) Standard Deviation 24.92	69.31 Millimeter (mm) Standard Deviation 23.48
Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24 Change at Week 24	-0.84 Millimeter (mm) Standard Deviation 31.22	-0.43 Millimeter (mm) Standard Deviation 30.25	-0.67 Millimeter (mm) Standard Deviation 22.42

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paliperidone n=179 Participants 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.	Paliperidone (Lack of Tolerability Group) n=47 Participants 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 (Lack of Compliance Group) n=58 Participants 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).
Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24 Baseline	40.57 Millimeter (mm) Standard Deviation 31.79	45.96 Millimeter (mm) Standard Deviation 31.18	46.55 Millimeter (mm) Standard Deviation 28.65
Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24 Change at Week 24	-1.18 Millimeter (mm) Standard Deviation 32.17	3.94 Millimeter (mm) Standard Deviation 28.02	10.05 Millimeter (mm) Standard Deviation 25.75

Adverse Events

Paliperidone

Serious events: 21 serious events

Other events: 112 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Paliperidone n=289 participants at risk 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.
General disorders Condition Aggravated	0.35% 1/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Injury, poisoning and procedural complications Ankle Fracture	0.35% 1/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Injury, poisoning and procedural complications Road Traffic Accident	0.35% 1/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Investigations Hepatic Enzyme Increased	0.35% 1/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Musculoskeletal and connective tissue disorders Muscle Rigidity	0.35% 1/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine Leiomyoma	0.35% 1/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Nervous system disorders Dizziness	0.35% 1/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Nervous system disorders Dystonia	0.35% 1/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Pregnancy, puerperium and perinatal conditions Ectopic Pregnancy	0.35% 1/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Psychiatric disorders Acute Psychosis	0.35% 1/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Psychiatric disorders Completed Suicide	0.69% 2/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Psychiatric disorders Delusion	0.35% 1/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Psychiatric disorders Hallucination, Auditory	1.0% 3/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Psychiatric disorders Insomnia	0.35% 1/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Psychiatric disorders Psychotic Behaviour	0.69% 2/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Psychiatric disorders Psychotic Disorder	0.35% 1/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Psychiatric disorders Schizophrenia	1.4% 4/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Psychiatric disorders Schizophrenia, Paranoid Type	0.35% 1/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Psychiatric disorders Social Avoidant Behaviour	0.35% 1/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Psychiatric disorders Suicidal Ideation	0.35% 1/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.

Other adverse events

Other adverse events
Measure	Paliperidone n=289 participants at risk 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.
Nervous system disorders Sedation	2.1% 6/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Nervous system disorders Somnolence	2.4% 7/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Nervous system disorders Tremor	4.8% 14/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Psychiatric disorders Insomnia	4.8% 14/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Gastrointestinal disorders Constipation	3.8% 11/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Gastrointestinal disorders Dry Mouth	2.8% 8/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Gastrointestinal disorders Dyspepsia	2.4% 7/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Gastrointestinal disorders Nausea	2.8% 8/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Investigations Weight Increased	2.1% 6/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Musculoskeletal and connective tissue disorders Muscle Rigidity	2.4% 7/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Nervous system disorders Akathisia	8.3% 24/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Nervous system disorders Bradykinesia	4.2% 12/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Nervous system disorders Dizziness	3.8% 11/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Nervous system disorders Dystonia	3.1% 9/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Nervous system disorders Essential Tremor	2.1% 6/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Nervous system disorders Extrapyramidal Disorder	4.8% 14/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.
Nervous system disorders Headache	3.5% 10/289 • Baseline up to Week 96 Safety population included all the participants who received paliperidone extended-release (ER) at least once.

Additional Information

Senior Clinical research Associate

Clinical Research Team, Medical Affairs Korea

Phone: 82-2-2094-4804

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60