Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.
A 6-Month, Open-Label, Single-Arm Safety Study of Flexibly Dosed Paliperidone Extended Release (1.5 - 12 mg/Day) in the Treatment of Adolescents (12 to 17 Years of Age) With Schizophrenia
2 other identifiers
interventional
400
11 countries
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started Jun 2007
Longer than P75 for phase_3 schizophrenia
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 18, 2007
CompletedFirst Posted
Study publicly available on registry
June 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
January 6, 2014
CompletedFebruary 10, 2017
November 1, 2013
5.1 years
June 18, 2007
July 12, 2013
December 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability
A serious adverse event as defined by the International Conference on Harmonisation (ICH) is any untoward medical occurrence that at any dose results in death, is life-threatening (the subject was at risk of death at the time of the even; it does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Up to 2 years
Secondary Outcomes (19)
Change From Open-label Baseline to Open-label Endpoint in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Scores - Last Observation Carried Forward
Baseline, Week 104 or the last post-baseline assessment
Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward
Baseline, Week 104 or the last post-baseline assessment
Change From Open-label Baseline to Open-label Endpoint in the Clinical Global Impression Severity (CGI-S) Scale - Last Observation Carried Forward
Baseline, Week 104 or the last post-baseline assessment
Change From Open-label Baseline to Open-label Endpoint in the Children's Global Assessment Scale (CGAS) - Last Observation Carried Forward
Baseline, Week 104 or the last post-baseline assessment
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Motor Speed Domain Test Variable, Finger Tapping Dominant- and Non-Dominant Hand, Scaled - Last Observation Carried Forward
Baseline, Week 24
- +14 more secondary outcomes
Study Arms (1)
001
EXPERIMENTALPaliperidone ER1.5 to 12 mg tablet once daily for 6 months
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Unknown Facility
Cerritos, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Middletown, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Jacksonville, Florida, United States
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Coeur d'Alene, Idaho, United States
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Chicago, Illinois, United States
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Lake Charles, Louisiana, United States
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Shreveport, Louisiana, United States
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Las Vegas, Nevada, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Antwerp, Belgium
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Sofia, Bulgaria
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Tallinn, Estonia
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Tartu, Estonia
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Viljandi, Estonia
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Hus, Finland
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Kellokoski, Finland
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Chennai, India
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Hyderabad, India
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Mangalore, India
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Varanasi, India
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Gdansk, Poland
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Lódź, Poland
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Poznan, Poland
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Sosnowiec, Poland
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Torun, Poland
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Warsaw, Poland
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Bucharest, Romania
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Ekaterinburg Na, Russia
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Kazan', Russia
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Moscow, Russia
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Moscow Russia, Russia
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Nizhny Novgorod, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Smolensk Region N/A, Russia
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Stavropol Na, Russia
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Tomsk Na, Russia
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Yaroslavl, Russia
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Cheonan, South Korea
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Gyeonggi-do, South Korea
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Kyunggi-Do, South Korea
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Seoul, South Korea
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Dnipro, Ukraine
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Hlevakha, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Odesa, Ukraine
Unknown Facility
Simferopol, Ukraine
Related Publications (1)
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.
PMID: 28660406DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director Clinical Research
- Organization
- Johnson & Johnson Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2007
First Posted
June 20, 2007
Study Start
June 1, 2007
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
February 10, 2017
Results First Posted
January 6, 2014
Record last verified: 2013-11