A Phase 4 Study to Evaluate Response to Treatment and Safety of Paliperidone Extended-Release in Participants With Schizophrenia

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

NCT00915512

CR016543

R076477SCH4027

Details and patient eligibility

About

The purpose of this study is to evaluate the response to treatment and safety of paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Full description

This is a non-randomized, single-arm, multi-center (conducted in more than one center) study to explore response to treatment and safety of flexible dose of paliperidone extended-release (ER) in participants with schizophrenia. During the study period, dose of paliperidone ER will remain within the range of 3 to 12 milligram per day and will be administered for 12 months. Both hospitalized and non-hospitalized participants may be included in the study. Participants may switch to any effective dose of paliperidone ER from any oral antipsychotic medication without dose adjustment or if required, cross-dose adjustment may be done. Maximum 4 weeks of switching period is allowed. Use of anticholinergic (opposing the actions of the acetylcholine, a neurotransmitter) drugs will not be restricted. Response to treatment will be evaluated primarily through total Personal and Social Performance (PSP) Scale. Participants' safety will be monitored throughout the study.

Enrollment

84 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Schizophrenia diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
Recent onset (less than 3 years after the first episode/hospitalization) schizophrenia but either not on antipsychotic medication for at least 3 months or in need of antipsychotic medication switches because of safety and/or lack of efficacy reasons
To be considered physically healthy at Screening according to vital signs and physical examination findings. If there are abnormalities, they must be consistent with the underlying illness in the study population
Women at postmenopausal state for at least 1 year; or undergone surgical sterilization, or for women with child-bearing status, should be willing to use an effective contraceptive method throughout the study
Participants who are willing and capable to complete the questionnaires

Exclusion criteria

Use of clozapine, depot neuroleptics or risperidone within the last 3 months
Any unstable clinical condition including clinically important abnormal laboratory findings
Previous and current tardive dyskinesia (abnormal involuntary movements which primarily affect the extremities, trunk, or jaw) symptoms
History of malignant neuroleptic syndrome
To be considered carrying high risk regarding adverse effects, homicide and/or suicide