A Study to Evaluate the Effectiveness and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia (PREVAIL)

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Treatments

Drug: Paliperidone palmitate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01527305

CR100739

PALM-KOR-4004 (Other Identifier)

PALM-KOR-4003 (Other Identifier)

R092670SCH4009 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness and safety of paliperidone palmitate in schizophrenic inpatients who have experienced recent exacerbation of acute schizophrenia (that is within past 4 weeks).

Full description

This is an open-label (all people know the identity of the intervention), prospective (looking forward using periodic observations collected predominantly following participant enrollment), non-comparative and multicenter study to evaluate the effectiveness and safety of paliperidone palmitate in acute schizophrenic participants. This study consists of a screening phase (up to 7 days), treatment phase (13 weeks), and a study completion or early withdrawal visit. Safety evaluations will include adverse events, clinical laboratory tests, concomitant medications, physical examination, and vital signs, which will be monitored throughout the study. The total duration of study participation for each participant will be approximately 13 weeks.

Enrollment

212 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM-IV)
Must be admitted to a hospital within 4 weeks prior to Screening experiencing an acute exacerbation of schizophrenia
Have a positive and negative syndrome scale (PANSS) total score of more than or equal to 60 or clinical global impressions - severity (CGI-S) score of more than or equal to 4 (moderately ill) at Screening
Agree to protocol-defined method of contraception
Must be medically stable based on physical examination, medical history, vital signs, and clinical laboratory tests performed at Screening

Exclusion criteria

Have a primary active DSM-IV Axis I diagnosis other than schizophrenia
Have evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal, neurological, endocrine, metabolic or pulmonary disease in medical history, clinical laboratory or physical examination
Have a history of neuroleptic malignant syndrome
Participants at risk of suicide
Have received clozapine within 1 month prior to Screening