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

Completed · Phase 3

Conditions studied: Schizophrenia, Schizophrenic Disorders, Psychotic Disorders, Dementia Praecox

In brief

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.

Key facts

Study ID

NCT00488319

Run by

Janssen Research & Development, LLC

People needed

400

Starts

2007-06-01

Expected to finish

2012-07-01

Last updated by the study team

2017-02-10

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — San Diego, California, United States
• Study site — Santa Ana, California, United States
• Study site — Middletown, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Jacksonville, Florida, United States
• Study site — Coeur d'Alene, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Lake Charles, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Antwerp, Belgium
• Study site — Sofia, Bulgaria
• Study site — Tallinn, Estonia
• Study site — Tartu, Estonia
• Study site — Viljandi, Estonia
• Study site — Hus, Finland
• Study site — Kellokoski, Finland
• Study site — Chennai, India
• Study site — Hyderabad, India
• Study site — Mangalore, India
• Study site — Varanasi, India
• Study site — Cerritos, California, United States

Full record on ClinicalTrials.gov

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