Safety and Efficacy Study of Paliperidone Extended Release (ER) Among Thai Schizophrenia Participants (PRESENT)

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Treatments

Drug: Paliperidone extended release (ER)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01387542

CR015976

R076477SCH4037 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) treatment in Thai schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.

Full description

This is an open-label (all people know the identity of the intervention), non-randomized (the study drug is not assigned by chance) study to evaluate the efficacy and safety of paliperidone ER in adult Thai schizophrenia participants. The study consists of a screening phase and an open-label treatment phase. Study duration will be 10 weeks and participants can either be inpatient or outpatient. The recommended paliperidone ER starting and maintenance dose will be 6 milligram (mg) per day for most participants. Throughout the study, flexible dosing ranging from 3 to 12 mg per day may be used at the discretion of the investigator. Throughout the study, participants will be evaluated for efficacy using clinician rating (Clinical and Global Impressions-Severity [CGI-S] scale, and Personal and Social Performance Scale [PSP]) scales. Safety of the participants will be monitored.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self)
Participants unsatisfied with their previous treatment
Previously or currently on oral atypical antipsychotics

Exclusion criteria

Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities
History or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body)
History of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
Pregnant or breast-feeding female
Participation in an investigational drug trial within 30 days prior to selection