Status:
COMPLETED
Efficacy and Safety of a Long Acting Anti-Psychotic Versus Placebo in Patients With Schizophrenia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the efficacy (how well the drug works), safety, and side effects of paliperidone palmitate compared to placebo in the treatment of the symptoms of schizophren...
Detailed Description
Many patients with schizophrenia have difficulty adhering to a daily oral treatment regimen. Long-acting injectable (LAI) formulations may provide therapeutic plasma concentrations over several weeks,...
Eligibility Criteria
Inclusion
- Patients who meet diagnostic criteria for schizophrenia according to DSM-IV for at least 1 year
- meet PANSS score criteria
- have body mass index (BMI) of \>15.0 kilogram(kg)/meter (m)2.
Exclusion
- Patients who have primary active DSM-IV Axis I diagnosis other than schizophrenia
- have a decrease of \>/=25% in the PANSS score
- have DSM-IV diagnosis of active substance dependence within 3 months of screening evaluation (nicotine and caffeine dependence are not exclusionary)
- have history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications
- have any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
- have significant risk of suicidal, homicidal or violent ideation or 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 :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
518 Patients enrolled
Trial Details
Trial ID
NCT00101634
Start Date
December 1 2004
End Date
March 1 2006
Last Update
June 8 2011
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