Clinical trial NCT00761579: Paliperidone Extended Release(ER) Effectiveness Study to Evaluate the Objective Symptom Change and Symptomatic Remission
Official title: An Open-Label Prospective, Non-Comparative Study To Explore The Tolerability, Safety and Effectiveness Upon Transition to Paliperidone Slow-Release Tablet in Schizophrenic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone
Antipsychotics Agents
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 190
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 investigate the safety and efficacy of flexibly dosed paliperidone extended-release (ER) 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, prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended Release(ER) in participants with schizophrenia (after switching from the existing drug to paliperidone ER). The total study duration will be approximately of 48 weeks per participant. The study consists of 2 parts: Screening (that is, 14 days before study commences on Day 1); Treatment (single-oral dose of paliperidone for 48 weeks, dose ranging from 3 to 12 milligram). Efficacy of the participants will primarily be evaluated by Positive and Negative Syndrome Scale. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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
* 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 (1) Group of lack of efficacy: the antipsychotic drug is clinically required to be changed because there is no or little therapeutic response despite the appropriately dosed antipsychotic therapy (2) Group of lack of tolerance: the antipsychotic drug is required to be changed due to lack of tolerance to the existing antipsychotic drug or the safety issue (3) Group of lack of compliance: the antipsychotic drug is required to be changed due to lack of medication compliance or the participant wants to change the antipsychotic drug)
* Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)

Exclusion Criteria:

* Participants with the past history of neuroleptic malignant syndrome (NMS)
* 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 significant abnormal findings in blood chemistry, hematological and urine analyses which are clinically significant at the investigator's discretion
* Female Participants who are pregnant or are breast feeding

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48
timeFrame: Baseline and Week 48
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 48
timeFrame: Baseline and Week 48
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 48
timeFrame: Baseline and Week 48
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score at Week 48
timeFrame: Baseline and Week 48
Secondary outcomes:
measure: Change From Baseline in Personal and Social Performance Scale (PSP) Score at Week 48
timeFrame: Baseline and Week 48
measure: Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 48
timeFrame: Baseline and Week 48
measure: Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale Score at Week 48
timeFrame: Baseline and Week 48
measure: Change From Baseline in Daytime Drowsiness at Week 48
timeFrame: Baseline and Week 48
measure: Change From Baseline in Sleep Quality at Week 48
timeFrame: Baseline and Week 48
measure: Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 48
timeFrame: Baseline and Week 48
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Chunjoo
country: Korea, Republic of
city: Dae-Gu
country: Korea, Republic of
city: Goyang-Si
country: Korea, Republic of
city: Ilsan
country: Korea, Republic of
city: Kyounggi
country: Korea, Republic of
city: Kyunggi-Do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: