An Efficacy and Safety Study of One Dosage of Paliperidone Extended Release (ER) in Treating Patients With Schizophrenia

Completed · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia

In brief

The purpose of this study is to assess the efficacy and safety of 1.5 mg/day dose of paliperidone Extended Release (ER) as compared with placebo when used to treat patients with schizophrenia.

Key facts

Study ID

NCT00524043

Run by

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

People needed

201

Starts

2007-09-01

Expected to finish

2008-11-01

Last updated by the study team

2014-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year before screening
• Experiencing an acute episode with a total PANSS score at screening of between 70 and 120
• Are otherwise physically healthy
• Agree to at least 8 days of voluntary hospitalization.

You may not qualify if…

• Active comorbid DSM-IV axis I diagnosis other than schizophrenia (nicotine and caffeine dependence are not exclusionary)
• Treatment with antidepressants (unless a subject has been on a stable dosage for at least 3 months before baseline) other than monoamine oxidase inhibitors
• DSM-IV diagnosis of substance dependence within 6 months before screening evaluation (nicotine and caffeine dependence are not exclusionary)
• Any medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as Crohn's disease, liver disease, or renal disease
• Relevant history of any significant or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic disease.

Where it is running

• Study site — Cerritos, California, United States
• Study site — Torrance, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Bradenton, Florida, United States
• Study site — Leesburg, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Rockville, Maryland, United States
• Study site — Nutley, New Jersey, United States
• Study site — Cedarhurst, New York, United States
• Study site — Hollis, New York, United States
• Study site — Moore, Oklahoma, United States
• Study site — Austin, Texas, United States
• Study site — Calicut, India
• Study site — Hyderabad, India
• Study site — Mumbai, India
• Study site — Pune, India
• Study site — Varanasi, India
• Study site — Hualien City, Taiwan
• Study site — Tainan, Taiwan
• Study site — Taipei, Taiwan

Full record on ClinicalTrials.gov

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