Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488319
Status:
COMPLETED
Last Update Posted:
2017-02-10
First Post:
2007-06-18
Brief Title:
Open-label Study of Flexible-dose Paliperidone ER Extended Release to Treat Adolescent Schizophrenia
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A 6-Month Open-Label Single-Arm Safety Study of Flexibly Dosed Paliperidone Extended Release 15 - 12 mgDay in the Treatment of Adolescents 12 to 17 Years of Age With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this open-label study is to evaluate the long-term 6-month safety and tolerability of extended-release paliperidone an atypical antipsychotic given in flexible dosages to adolescents with schizophrenia
Detailed Description:
This is a 6-month open-label study the patient investigator and sponsor know the study drug and dosage being taken by the patient of the safety and tolerability of flexible-dose 15 to 12mg per day extended-release ER paliperidone in adolescents with a diagnosis of schizophrenia Patients who have completed study R076477PSZ3001 or who discontinued from that study because of lack of efficacy but completed a minimum of 21 days of the study may enter this study Patients may also enter this study directly without participating in R076477PSZ3001 This study consists of a 21-day screening and washout phase to discontinue and wash out any medication not allowed in the study an open-label treatment phase of up to 26 weeks during which all patients will take oral paliperidone ER every day and a post-treatment phase consisting of a follow-up visit completed 1 week after a patient has received the final dose of paliperidone ER The study including the screening and posttreatment phase will last approximately 30 weeks Screening and washout may be conducted while a patient is either an inpatient or an outpatient Safety will be assessed by laboratory measurements chemistry liver function tests hematology hormone lipid assessments prolactin blinded urinalysis and urine drug screens body weight height and waist circumference measurements ECGs and physical examinations including Tanner staging The Abnormal Involuntary Movement Scale AIMS Barnes Akathisia Rating Scale BARS and Simpson Angus Rating Scale SAS will be used to assess extrapyramidal symptoms EPS and dyskinesias Adverse events will be monitored including psychiatric adverse events of interest ie suicide and related phenomena homicidal ideation depressed mood and worsening of psychosis that may be associated with paliperidone ER in this population The primary aim of this study is to evaluate the long-term 6-month safety and tolerability of paliperidone ER in adolescents with schizophrenia As exploratory secondary aims the study will assess the effect of paliperidone ER on the long-term symptoms of schizophrenia as measured by the changes in the Positive and Negative Syndrome Scale for Schizophrenia PANSS scores the global improvement in severity of illness as measured by the Clinical Global Impression-Severity CGI-S scale the benefits in psychological social and school functioning as measured by the Childrens Global Assessment Scale CGAS the changes in multiple domains of cognitive functioning measured by the modified Measurements and Treatment Research to Improve Cognition in Schizophrenia MATRICS assessment battery and the effect on sleep as measured by the sleep Visual Analog Scale VAS Patients begin the study at 60 mgday of oral paliperidone ER If a higher dosage is needed the dosage will be increased in increments of 3 mgday not more frequently than once every 5 days to 12 mgday If the 60 mgday dosage is not well tolerated the dosage may be decreased not more frequently than once every 5 days to 30 mgday or 15 mgday Patients will be dosed for up to 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R076477PSZ3002 | OTHER | Janssen Research Development LLC | None |