A Study of the Efficacy (Effectiveness) of Paliperidone Palmitate in the Prevention of Recurrence of the Symptoms of Schizophrenia.

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

The purpose of this study is to evaluate the efficacy of paliperidone palmitate compared with placebo in the prevention of recurrence of the symptoms of schizophrenia and to assess the safety and tolerability of paliperidone palmitate in patients with stable and symptomatic schizophrenia. The placebo used in this study was a nutritional substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings.

Key facts

Study ID

NCT00111189

Run by

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

People needed

414

Starts

2005-02-01

Expected to finish

2008-02-01

Last updated by the study team

2014-06-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who meet the diagnostic criteria for schizophrenia according to DSM-IV-TM for at least 1 year before screening
• have a PANSS score of <120
• have a body mass index (BMI) >/=15.0 kilogram (kg)/meter (m)2
• and have resided at the same address for at least 30 days

You may not qualify if…

• Patients unable to provide their own consent
• have been involuntarily committed to psychiatric hospitalization
• have primary, active DSM-IV-TM diagnosis other than schizophrenia
• who have a DSM-IV-TM diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
• have a history of treatment resistance as defined by failure to respond to 2 adequate trials (minimum of 4 weeks at a therapeutic dose) of different antipsychotic medications
• have a history of any severe preexisting gastrointestinal narrowing or inability to swallow the medication whole with water
• have a history of neuroleptic malignant syndrome (NMS)
• are at significant risk of suicidal or violent behavior
• current presence of any significant or unstable medication condition
• treatment with any protocol disallowed therapies
• clinically significant result from screening laboratory or ECG.

Where it is running

• Study site — Cerritos, California, United States
• Study site — Santa Ana, California, United States
• Study site — Hialeah, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Granite City, Illinois, United States
• Study site — Lake Charles, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Flowood, Mississippi, United States
• Study site — St Louis, Missouri, United States
• Study site — Clementon, New Jersey, United States
• Study site — Cedarhurst, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Conroe, Texas, United States
• Study site — DeSoto, Texas, United States
• Study site — Irving, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Costa Rica, Costa Rica
• Study site — Mexico City, Mexico
• Study site — Mérida, Mexico
• Study site — Monterrey, Mexico
• Study site — Bucharest, Romania
• Study site — Cluj-Napoca, Romania
• Study site — Iași, Romania
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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