PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia

NCT ID: NCT00761189

Last Updated: 2014-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 491 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-07-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paliperidone

Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.

Group Type: EXPERIMENTAL

Paliperidone

Intervention Type: DRUG

Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.

Interventions

Paliperidone

Paliperidone extended-release (ER) tablet will be administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.

Intervention Type: DRUG

Other Intervention Names

R076477; Invega extended-Release (ER) tablet

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Korea, Ltd., Korea Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Locations

Bucheon-Si Gyeonggi-Do, , South Korea

Changnyung, , South Korea

Chunjoo, , South Korea

Daejeon, , South Korea

Daejun, , South Korea

Geonggi-Do, , South Korea

Gyeonggi-do, , South Korea

Incheon, , South Korea

Inchun, , South Korea

Jinju, , South Korea

Jungnam, , South Korea

Kwangjoo, , South Korea

Kyounggi, , South Korea

Kyunggi-Do, , South Korea

Kyungju, , South Korea

Kyungki, , South Korea

Kyunki, , South Korea

Pusan, , South Korea

Seoul, , South Korea

Ulsan, , South Korea

Countries

South Korea

Other Identifiers

PAL-KOR-4001

Identifier Type: -

Identifier Source: secondary_id

CR015079

Identifier Type: -

Identifier Source: org_study_id