Status:
COMPLETED
A Safety and Pharmacokinetic Study of Paliperidone Palmitate in Patients With Schizophrenia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the long term safety of flexible doses (50 to 150 mg equivalent) of paliperidone palmitate in the treatment of patients with schizophrenia and to document the ...
Detailed Description
This is an open-label (identity and dose of study drug will be known to patients), safety and pharmacokinetic study of the highest dose (150 mg equivalent) of paliperidone palmitate (referred to as st...
Eligibility Criteria
Inclusion
- Meet the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for at least 1 year before screening
- Have a body mass index (BMI) of \>=17.0 kg/m2 at screening
- Have a Positive and Negative Syndrome Scale (PANSS) total score of \<=70
Exclusion
- Have a primary active DSM-IV Axis I diagnosis other than schizophrenia
- Have a PANSS total score of \>70 at screening
- Have a PANSS score of \>16 points on the sum of the following 4 items at screening and baseline: conceptual disorganization, suspiciousness/persecution, hallucinatory behavior, and unusual thought content
- Have scores greater than 5 on any of the individual items of the PANSS at screening or baseline
- Have attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior as clinically assessed by the investigator
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT01150448
Start Date
September 1 2007
End Date
June 1 2009
Last Update
May 28 2014
Active Locations (28)
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1
Cerritos, California, United States
2
National City, California, United States
3
San Diego, California, United States
4
Atlanta, Georgia, United States