Clinical trial NCT00761189: PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia
Official title: An Open Label, Prospective, Non-comparative Study to Evaluate Flexible Dose of Paliperidone Extended-Release and Clinical Response in the Treatment of Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Paliperidone
R076477
Schizophrenia
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 491
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 the efficacy of 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 (all people know the identity of the intervention), multi-centric (conducted in more than one center), prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended Release(ER) in participants with schizophrenia. The total study duration will be approximately of 104 weeks per participant. The study consists of following parts: Screening (that is, 14 days before study commences on Day 1); acute Treatment phase (single-oral dose of paliperidone for 12 weeks, dose ranging from 3 to 12 milligram); Extension phase 1 (12 weeks) and Maintenance treatment which will be followed by additional Extension phase 2 and long-term maintenance treatment. Efficacy of the participants will primarily be evaluated by Clinical Global Impression-Improvement (CGI-I) scale score. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening
* Childbearing potential women who consent to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
* Participants who are capable of and willing to fill out the questionnaire for themselves
* Participants who are compliant with self-medication or can receive consistent help or support
* 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 with Treatment Resistance history who have failed to be properly treated with more than two other kinds of antipsychotic agents (at least 4 weeks of the therapeutic dose administration)
* Participants with severe (pathologic or iatrogenic) gastrointestinal stenosis or participants who can not 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 who have been exposed to the study drug within one month before screening
* Participants with significant risk including suicide or aggressive behavior

Primary outcomes:
measure: Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
timeFrame: Week 12
measure: Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population
timeFrame: Week 12
Secondary outcomes:
measure: Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population
timeFrame: Baseline, Week 4 and 12
measure: Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population
timeFrame: Baseline, Week 4 and Week 12
measure: Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population
timeFrame: Week 12
measure: Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population
timeFrame: Week 12
measure: Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population
timeFrame: Baseline, Week 4 and 12
measure: Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population
timeFrame: Baseline, Week 4 and 12
measure: Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population
timeFrame: Baseline, Week 2, 4, 8 and 12
measure: Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population
timeFrame: Baseline, Week 2, 4, 8 and 12
measure: Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
timeFrame: Week 12
measure: Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population
timeFrame: Week 12
Other outcomes:
Locations:
city: Bucheon-Si Gyeonggi-Do
country: Korea, Republic of
city: Changnyung
country: Korea, Republic of
city: Chungnam
country: Korea, Republic of
city: Chunjoo
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Daejun
country: Korea, Republic of
city: Geonggi-Do
country: Korea, Republic of
city: Gyeonggi-Do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Inchun
country: Korea, Republic of
city: Jinju
country: Korea, Republic of
city: Kwangjoo
country: Korea, Republic of
city: Kyounggi
country: Korea, Republic of
city: Kyunggi-Do
country: Korea, Republic of
city: Kyungju
country: Korea, Republic of
city: Kyungki
country: Korea, Republic of
city: Kyunki
country: Korea, Republic of
city: Pusan
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Ulsan
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: