Status:
COMPLETED
Safety and Efficacy of an Anti-Psychotic in Patients With Schizophrenia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the efficacy (how well the drug works), safety, and side effects of paliperidone palmitate injection compared to placebo in the treatment of the symptoms of s...
Detailed Description
Paliperidone palmitate is an aqueous suspension that releases paliperidone gradually over a period of about 1 month and is under development to provide a sustained and stable level of paliperidone. Th...
Eligibility Criteria
Inclusion
- Patients diagnosed with schizophrenia
- for at least 1 year before screening
- meet PANSS score criteria
- must agree to hospitalization for a minimum of 14 days
- body mass index (BMI) \<35.0 kilogram (kg)/meter (m)2.
Exclusion
- Patients who are involuntarily committed as in-patients
- have a DSM-IV Axis I diagnosis other than schizophrenia
- have a DSM-IV diagnosis of substance dependence within 3 months before screening (nicotine, caffeine dependence, and history of recreational use of marijuana are not exclusionary)
- have a decrease of \>/=25% in the PANSS score between screening and predose
- previous lack of response to 2 adequate trials of antipsychotic treatment
- have a significant risk of suicidal, homicidal, or violent ideation or behavior
- have severe gastrointestinal narrowing (pathologic or iatrogenic)
- 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 :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00074477
Start Date
October 1 2003
End Date
July 1 2004
Last Update
May 24 2011
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