Status:
COMPLETED
A Study of the Efficacy (Effectiveness) of Paliperidone Palmitate in the Prevention of Recurrence of the Symptoms of Schizophrenia.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Janssen-Cilag International NV
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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 tole...
Detailed Description
Many patients with schizophrenia have difficulty adhering to a daily oral treatment regimen. Long-acting injectable formulations, such as long-acting injectable paliperidone palmitate, may provide the...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT00111189
Start Date
February 1 2005
End Date
February 1 2008
Last Update
June 20 2014
Active Locations (55)
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1
Little Rock, Arkansas, United States
2
Cerritos, California, United States
3
Santa Ana, California, United States
4
Hialeah, Florida, United States