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

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Paliperidone

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Paliperidone Extended-release, Paliperidone, R076477

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paliperidone

Arm Description

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.

Outcomes

Primary Outcome Measures

Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at 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.

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.

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.

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.

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.

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.

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).

Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 24

Secondary Outcome Measures

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT00784238

First Posted

October 31, 2008

Last Updated

February 7, 2014

Sponsor

Janssen Korea, Ltd., Korea

1. Study Identification

Unique Protocol Identification Number

NCT00784238

Brief Title

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

Acronym

Power

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 Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Korea, Ltd., Korea

4. Oversight

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

Schizophrenia, Paliperidone Extended-release, Paliperidone, R076477

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

289 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paliperidone

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Paliperidone

Other Intervention Name(s)

R076477, Invega Extended-release tablet

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Week 24

Title

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

Description

Time Frame

Baseline and Week 24

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

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

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

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

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

Title

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

Description

Time Frame

Week 24

Title

Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 24

Description

Time Frame

Baseline and Week 24

Secondary Outcome Measure Information:

Title

Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Krawiecka Scale Score at Week 24

Description

Time Frame

Baseline and Week 24

Title

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

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24

Description

Time Frame

Baseline and Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Korea, Ltd., Korea Clinical Trial

Organizational Affiliation

Janssen Korea, Ltd., Korea

Official's Role

Study Director

Facility Information:

City

Busan

Country

Korea, Republic of

City

Changnyeong-Gun

Country

Korea, Republic of

City

Chonju

Country

Korea, Republic of

City

Chun-An

Country

Korea, Republic of

City

Chungcheongbuk-Do

Country

Korea, Republic of

City

Dae-Jeon

Country

Korea, Republic of

City

Daegu

Country

Korea, Republic of

City

Daejeon

Country

Korea, Republic of

City

Hwasun Gun

Country

Korea, Republic of

City

Iksan

Country

Korea, Republic of

City

Kwangjoo

Country

Korea, Republic of

City

Naju

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

22516251

Citation

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.

Results Reference

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

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