SchizophreniaPhase 4PowerNCT00784238

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

A Phase 4 study testing Paliperidone in people with Schizophrenia, run by Janssen Korea, Ltd., Korea at 11 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: Paliperidone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 289 participants
Where: 11 sitesSouth Korea
Study dates: Apr 2008to Jan 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

South Korea11 sites

Study site
Busan
Study site
Changnyeong
Study site
Chungcheongbuk-Do
Study site
Daegu
Study site
Daejeon
Study site
Hwasun Gun
Study site
Iksan
Study site
Jeonju
Study site
Junam
Study site
Kwangjoo
Study site
Naju

Other trials in South Korea

About this study

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

Read the 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.

Conditions: Schizophrenia
Being tested: Paliperidone
Keywords: Schizophrenia, Paliperidone Extended-release, Paliperidone, R076477
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PaliperidoneDrug
Also called R076477, Invega Extended-release tablet
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.

Study groups in NCT00784238
Study group	Role	What they receive
Paliperidone	Experimental	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. Receives: Drug: Paliperidone

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at 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.
Measured: Week 24
Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at 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.
Measured: Baseline and Week 24
Change From Baseline in Mental Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at 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.
Measured: Baseline and Week 24
Change From Baseline in Self-Control Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at 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.
Measured: Baseline and Week 24
Change From Baseline in Emotional Regulation Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at 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.
Measured: Baseline and Week 24
Change From Baseline in Physical Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at 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.
Measured: Baseline and Week 24
Change From Baseline in Social Integration Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at 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.
Measured: Baseline and Week 24
Drug Attitude Inventory (DAI-10) Total Score at 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).
Measured: Week 24
Change From Baseline in Drug Attitude Inventory (DAI-10) at 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.
Measured: Baseline and Week 24

Secondary outcomes (5)

Change From Baseline in Symptom Checklist 90-R (SCL90-R) at 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.
Measured: Baseline and Week 24
Change From Baseline in Krawiecka Scale Score at 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.
Measured: Baseline and Week 24
Change From Baseline in Total Personal and Social Performance (PSP) Score at 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.
Measured: Baseline and Week 24
Change From Baseline in Sleep Quality Based on Visual Analog Scale at 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.
Measured: Baseline and Week 24
Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at 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.
Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008Jan 2011

First posted3 Nov 2008 (estimated)
Study startApr 2008
Primary completionDec 2010
Study completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 289 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00784238
Sponsor's protocol ID: CR015391
Other IDs: R076477SCH4028
Acronym: Power
Status last verified: Feb 2014
First submitted: 31 Oct 2008
Last updated: 27 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kim SW, Yoon JS, Kim YS, Ahn YM, Kim CE, Go HJ, Chee IS, Jung SW, Chung YC, Kim YD, Joe S, Lee J, Kwon YJ, Yoon BH, Jae YM. The effect of paliperidone extended release on subjective well-being and responses in patients with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2012 Aug 7;38(2):228-35. doi: 10.1016/j.pnpbp.2012.04.004. Epub 2012 Apr 10.
PubMed 22516251

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00784238
Acronym / sponsor ID: Power / CR015391
Conditions: Schizophrenia
Keywords: Schizophrenia, Paliperidone Extended-release, Paliperidone, R076477
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 289 participants (actual)
Lead sponsor: Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Dec 2010 (actual)
Study completion: Jan 2011 (actual)
First posted: 3 Nov 2008 (estimated)
Results: Posted 27 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Paliperidone	Experimental	Drug: PaliperidonePaliperidone 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PaliperidoneAlso: R076477, Invega Extended-release tabletPaliperidone 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

Primary outcome

Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at Week 24
Time frame: 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 in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Time frame: 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.
Change From Baseline in Mental Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Time frame: 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.
Change From Baseline in Self-Control Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Time frame: 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.
Change From Baseline in Emotional Regulation Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Time frame: 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.
Change From Baseline in Physical Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Time frame: 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.
Change From Baseline in Social Integration Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Time frame: 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.
Drug Attitude Inventory (DAI-10) Total Score at Week 24
Time frame: 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 in Drug Attitude Inventory (DAI-10) at Week 24
Time frame: 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.

5 secondary outcomes

Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Krawiecka Scale Score at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24
Time frame: Baseline and Week 24
Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 27 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paliperidone	289	170

Primary outcome: Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at Week 24

Time frame: Week 24. Mean (Standard Deviation). Unit: Units on a scale

Measure	Paliperidone n = 284
Value	77.89 (17.95)

Population analysed: 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.

Primary outcome: Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24

Time frame: Baseline and Week 24. Mean (Standard Deviation). Unit: Units on a scale

Measure	Paliperidone (Lack of Efficacy Group) n = 179	Paliperidone (Lack of Tolerability Group) n = 47	Paliperidone (Lack of Compliance Group) n = 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)

Population analysed: 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.

Primary outcome: Change From Baseline in Mental Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24

Time frame: Baseline and Week 24. Mean (Standard Deviation). Unit: Units on a scale

Measure	Paliperidone (Lack of Efficacy Group) n = 179	Paliperidone (Lack of Tolerability Group) n = 47	Paliperidone (Lack of Compliance Group) n = 58
Value	-0.14 (3.56)	-0.51 (3.62)	-0.24 (4.79)

Population analysed: 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.

Primary outcome: Change From Baseline in Self-Control Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24

Time frame: Baseline and Week 24. Mean (Standard Deviation). Unit: Units on a scale

Measure	Paliperidone (Lack of Efficacy Group) n = 179	Paliperidone (Lack of Tolerability Group) n = 47	Paliperidone (Lack of Compliance Group) n = 58
Value	-0.72 (3.74)	-0.62 (4.05)	-0.29 (4.07)

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Week 96. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paliperidone	21 of 289 (7.3%)	112 of 289 (38.8%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22516251Kim SW, Yoon JS, Kim YS, Ahn YM, Kim CE, Go HJ, Chee IS, Jung SW, Chung YC, Kim YD, Joe S, Lee J, Kwon YJ, Yoon BH, Jae YM. The effect of paliperidone extended release on subjective well-being and responses in patients with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2012 Aug 7;38(2):228-35. doi: 10.1016/j.pnpbp.2012.04.004. Epub 2012 Apr 10.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Korea, Ltd., Korea Clinical Trial study director

Janssen Korea, Ltd., Korea

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Paliperidone in people with Schizophrenia, run by Janssen Korea, Ltd., Korea at 11 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at Week 24 (time frame: Week 24). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00784238, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2014.