A Double-blind, Placebo-controlled Study of the Safety and Efficacy of Paliperidone Extended Release (ER) in the Treatment of Schizophrenia in Adolescent Patients

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

The purpose of this study is to evaluate the efficacy, safety, and tolerability of 3 weight-based, fixed-dose groups of paliperidone extended release (ER) compared with placebo in adolescent patients between 12 to 17 years of age, who are diagnosed with schizophrenia. Paliperidone ER is an atypical antipsychotic agent approved by the U.S. Food and Drug Administration for the treatment of schizophrenia in adults. Patients may be voluntary inpatients or outpatients at the time of the screening visit, but should have returned to their usual living situation by Day 21 of the double-blind treatment phase. The study duration is approximately 10 weeks. Patients who have completed this study or who were discontinued from this study due to lack of efficacy but have completed at least 21 days of double-blind treatment and are expected to benefit from paliperidone treatment, may enter an optional open-label safety study.

Key facts

Study ID

NCT00518323

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

201

Starts

2007-08-01

Expected to finish

2009-03-01

Last updated by the study team

2014-04-16

Who can join

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

You may qualify if…

• Must meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) criteria for schizophrenia (295.10, 295.20, 295.30, 295.60, 295.90) for 1 year (the diagnosis will be established using the K-SADS-PL, including all supplements)
• Must not be a danger to themselves or others, and must have family support available to be maintained as an outpatient
• Should have had at least 1 adequate treatment with an antipsychotic before participation in this study
• Must have a PANSS score between 60 and 120, inclusive, at screening and baseline
• Weight >=29 kg

You may not qualify if…

• Meet the DSM-IV criteria at screening for dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance induced psychotic disorder. Other comorbid disorders e.g., attention-deficit hyperactivity disorder (ADHD) are allowed as long as the diagnosis of schizophrenia is the primary diagnosis and the comorbid disorders in the investigator's judgment do not require medication
• Mild, moderate, or severe mental retardation (i.e., documented intelligence quotient [IQ] <70) established by previous IQ testing or history
• Women who are pregnant (as confirmed by urine pregnancy test performed at screening or baseline), planning to become pregnant or are nursing
• Have a known or suspected history of seizure disorder, or neuroleptic malignant syndrome, encephalopathic syndrome, tardive dyskinesia, or insulin dependent diabetes mellitus
• Presence of any significant or unstable cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease

Where it is running

• Study site — Cerritos, California, United States
• Study site — Fountain Valley, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Ana, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Lake Charles, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Cleveland, Ohio, United States
• Study site — Portsmouth, Virginia, United States
• Study site — Spokane, Washington, United States
• Study site — Bangalore, India
• Study site — Chennai, India
• Study site — Hyderabad, India
• Study site — Hyderabad Andra Pradesh, India
• Study site — Mangalore, India
• Study site — New Delhi, India
• Study site — Varanasi, India
• Study site — Bucharest, Romania
• Study site — Ekaterinburg Na, Russia
• Study site — Kazan', Russia
• Study site — Moscow, Russia
• Study site — Moscow Russia, Russia
• Study site — Nizhny Novgorod, Russia
• Study site — Saint Petersburg, Russia
• Study site — Saratov, Russia

Full record on ClinicalTrials.gov

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