Clinical trial NCT00784238: Efficacy Study of Paliperidone to Evaluate Subjective Change in Well-being and Drug Attitude in Schizophrenic Participants
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone Extended-release
Paliperidone
R076477
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2008-11-02
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Subjective Well-being Under Neuroleptic (SWN-20) Scale Total Score at Week 24
timeFrame: Week 24
measure: Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Mental Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Self-Control Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Emotional Regulation Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Physical Functioning Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Social Integration Subscale Score Based on Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
timeFrame: Baseline and Week 24
measure: Drug Attitude Inventory (DAI-10) Total Score at Week 24
timeFrame: Week 24
measure: Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Krawiecka Scale Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
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
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References:
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.