An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia

Completed · Phase 3

Conditions studied: Schizophrenia

In brief

The purpose of this study is to evaluate the efficacy and safety of extended-release (ER) paliperidone compared to aripiprazole (atypical antipsychotic) in symptomatic (having symptoms) adolescent participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations \[imagining things\], and withdrawal into the self) .

Key facts

Study ID

NCT01009047

Run by

Janssen Research & Development, LLC

People needed

228

Starts

2009-12-01

Expected to finish

2012-06-01

Last updated by the study team

2013-06-21

Who can join

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

You may qualify if…

• Participants must currently meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for schizophrenia and have experienced symptoms of the illness for at least 1 year, and they should have had at least treatment with 1 antipsychotic before participation in this study
• Participants having a Positive and Negative Syndromes Scale (PANSS) score between 60 and 120 inclusive at Screening
• Female participants must be incapable of pregnancy, or if heterosexually active and capable of pregnancy, have been using an acceptable method of contraception for at least 1 month before study entry and agree to continue use contraception methods for the duration of the study, or if sexually abstinent (not having sexual intercourse) and capable of pregnancy, must agree to continue abstinence or to use an acceptable method of birth control
• Participants must not be a danger to themselves or others, and must have family support available to be maintained as out-patients
• Participants with a weight of equal to or greater than 29 kilogram

You may not qualify if…

• Participants with mild (not serious), moderate (medium level of seriousness), or severe (very serious, life threatening) mental retardation
• Participants with a known or suspected history of substance dependence (including alcohol, but excluding nicotine or caffeine) as per the DSM-IV criteria in the 3 months before Screening
• Participants with a history of certain neurological (pertaining to the nervous system) disorders or insulin-dependent diabetes mellitus (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects)
• Participants who have received a depot injectable antipsychotic within 2 treatment cycles before the Screening visit
• Participants who have received clozapine in 2 months before the Baseline visit (Day 1 of Week 1)

Where it is running

• Study site — Dothan, Alabama, United States
• Study site — Santa Ana, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Smyrna, Georgia, United States
• Study site — Lake Charles, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Jaipur, India
• Study site — Kanpur Uttarpradeh, India
• Study site — Lucknow Gpo, India
• Study site — Mangalore, India
• Study site — Varanasi, India
• Study site — Bucharest, Romania
• Study site — Chelyabinsk, Russia
• Study site — Ekaterinburg Na, Russia
• Study site — Krasnodar, Russia
• Study site — Moscow, Russia
• Study site — Moscow Russia, Russia
• Study site — Nizhny Novgorod, Russia
• Study site — Novosibirsk, Russia
• Study site — Saint Petersburg, Russia
• Study site — Samara, Russia
• Study site — Saratov, Russia
• Study site — Smolensk Region N/A, Russia
• Study site — Tomsk Na, Russia
• Study site — Yaroslavl, Russia

Full record on ClinicalTrials.gov

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