Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.

NCT ID: NCT00488319

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2012-07-31

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 (1.5 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 (i.e., 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 Children's 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 6.0 mg/day of oral paliperidone ER. If a higher dosage is needed, the dosage will be increased (in increments of 3 mg/day not more frequently than once every 5 days) to 12 mg/day. If the 6.0 mg/day dosage is not well tolerated, the dosage may be decreased (not more frequently than once every 5 days) to 3.0 mg/day or 1.5 mg/day. Patients will be dosed for up to 6 months.

Conditions

Schizophrenia; Schizophrenic Disorders; Psychotic Disorders; Dementia Praecox

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

001

Paliperidone ER1.5 to 12 mg tablet once daily for 6 months

Group Type: EXPERIMENTAL

Paliperidone ER

Intervention Type: DRUG

1.5 to 12 mg tablet once daily for 6 months

Interventions

Paliperidone ER

1.5 to 12 mg tablet once daily for 6 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Meets the DSM-IV criteria for schizophrenia, otherwise physically healthy
• Weight >=63.9 pounds (29 kg)
• Must not be a danger to self or others and must have family support available to be maintained as outpatients
• Responsible adult must be available to accompany the patient to the investigational site at each visit.

Exclusion Criteria

• Meets the DSM-IV criteria for dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance-induced psychotic disorder
• mild, moderate, or severe mental retardation
• History of substance dependence (including alcohol, but excluding nicotine and caffeine) according to the DSM-IV criteria in the 3 months before screening
• pregnancy (for females)
• History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death in association with the use of drugs that prolong the QTc interval.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Cerritos, California, United States

San Diego, California, United States

Santa Ana, California, United States

Middletown, Connecticut, United States

Washington D.C., District of Columbia, United States

Jacksonville, Florida, United States

Coeur d'Alene, Idaho, United States

Chicago, Illinois, United States

Lake Charles, Louisiana, United States

Shreveport, Louisiana, United States

Las Vegas, Nevada, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Oklahoma City, Oklahoma, United States

Antwerp, , Belgium

Sofia, , Bulgaria

Tallinn, , Estonia

Tartu, , Estonia

Viljandi, , Estonia

Hus, , Finland

Kellokoski, , Finland

Chennai, , India

Hyderabad, , India

Mangalore, , India

Varanasi, , India

Gdansk, , Poland

Lódź, , Poland

Poznan, , Poland

Sosnowiec, , Poland

Torun, , Poland

Warsaw, , Poland

Bucharest, , Romania

Ekaterinburg Na, , Russia

Kazan', , Russia

Moscow, , Russia

Moscow Russia, , Russia

Nizhny Novgorod, , Russia

Saint Petersburg, , Russia

Saratov, , Russia

Smolensk Region N/A, , Russia

Stavropol Na, , Russia

Tomsk Na, , Russia

Yaroslavl, , Russia

Cheonan, , South Korea

Gyeonggi-do, , South Korea

Kyunggi-Do, , South Korea

Seoul, , South Korea

Dnipro, , Ukraine

Hlevakha, , Ukraine

Kharkiv, , Ukraine

Kiev, , Ukraine

Odesa, , Ukraine

Simferopol, , Ukraine

Countries

United States; Belgium; Bulgaria; Estonia; Finland; India; Poland; Romania; Russia; South Korea; Ukraine

References

Gopal S, Lane R, Nuamah I, Copenhaver M, Singh J, Hough D, Bach M, Savitz A. Evaluation of Potentially Prolactin-Related Adverse Events and Sexual Maturation in Adolescents with Schizophrenia Treated with Paliperidone Extended-Release (ER) for 2 Years: A Post Hoc Analysis of an Open-Label Multicenter Study. CNS Drugs. 2017 Sep;31(9):797-808. doi: 10.1007/s40263-017-0437-9.

Reference Type: DERIVED

PMID: 28660406 (View on PubMed)

Other Identifiers

R076477PSZ3002

Identifier Type: OTHER

Identifier Source: secondary_id

CR012616

Identifier Type: -

Identifier Source: org_study_id