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Paliperidone Extended Release(ER) Effectiveness Study to Evaluate the Objective Symptom Change and Symptomatic Remission | Clinical Trials | Clareo Health

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Paliperidone Extended Release(ER) Effectiveness Study to Evaluate the Objective Symptom Change and Symptomatic Remission

An Open-Label Prospective, Non-Comparative Study To Explore The Tolerability, Safety and Effectiveness Upon Transition to Paliperidone Slow-Release Tablet in Schizophrenic Patients

NCT00761579•Janssen Korea, Ltd., Korea

View on ClinicalTrials.gov

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (8)

Busan, South Korea

Chunjoo, South Korea

Daegu, South Korea

Goyang-si, South Korea

Ilsan, South Korea

Kyounggi, South Korea

Kyunggi-Do, South Korea

Seoul, South Korea

Key Dates

Start Date

April 1, 2008

Primary Completion Date

October 1, 2010

Completion Date

December 1, 2010

Last Updated

June 3, 2014

Enrollment

190

ACTUAL participants

Conditions

Schizophrenia

Interventions

Paliperidone

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Paliperidone Extended Release(ER) Effectiveness Study to Evaluate the Objective Symptom Change and Symptomatic Remission

Inclusion Criteria

Exclusion Criteria

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