Paliperidone Extended Release in Schizophrenia Participants With Duration of Illness Less Than 10 Years

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Treatments

Drug: Paliperidone ER

Study type

Interventional

Funder types

Industry

Identifiers

NCT01362439

CR017578

2008-002384-13

R076477SCH3037

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) in symptomatic participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were receiving treatment with any oral (having to do with the mouth) antipsychotic medication and who needed to be switched to paliperidone ER from the current oral antipsychotic therapy due to insufficient efficacy or due to side effects.

Full description

This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of paliperidone ER in participants with schizophrenia who have a previous history of bad adherence to the antipsychotic treatment because of insufficient efficacy and side-effects. All the eligible participants will receive a dose of paliperidone ER in range of 3 to 12 milligram (mg) orally (taken by mouth; to be swallowed) once daily for 13 weeks. Efficacy and safety will primarily be evaluated by Positive and Negative Syndromes Scale (PANSS) and Extrapyramidal Symptom Rating Scale (ESRS), respectively. Participants' safety will be monitored throughout the study.

Enrollment

133 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (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)
Positive and Negative Syndrome Scale (PANSS) total score at Baseline of greater than equal to 70 and less than equal to 100
Participants who need to be switched from the current oral antipsychotic therapy because of lack of efficacy or side effects
Participants followed as outpatients
Female participants must be postmenopausal for at least 1 year, surgically sterile or, if sexually active, be practicing an effective method of birth control and female participants of childbearing potential must also have a negative urine pregnancy test at Baseline

Exclusion criteria

Acute psychotic relapse that requires hospitalization and first antipsychotic treatment ever
Participants who had received clozapine during the previous 3 months
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) and 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
Participated in an investigational drug trial in the previous 30 days