Status:
COMPLETED
A Study of Paliperidone Palmitate in Japanese Patients With Schizophrenia
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Schizophrenia
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate the long-term safety and tolerability of paliperidone palmitate in Japanese patients with schizophrenia. Secondary objectives of this study are to: e...
Detailed Description
This is an open-label, flexible-dose, multicenter study. The study will consist of 3 periods: an up-to-2-week pre-observation (screening) period, an observation period from Day 1 (baseline) to Week 49...
Eligibility Criteria
Inclusion
- Met diagnostic criteria for schizophrenia according to DSM-IV-TR (disorganized type \[295.10\], catatonic type \[295.20\], paranoid type \[295.30\], residual type \[295.60\], or undifferentiated type \[295.90\]) for at least 1 year before screening. Prior medical records, written documentation or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
- A PANSS total score of 60 to 120 at screening and baseline (Day 1)
- Documented history of exposure to either a risperidone formulation or a paliperidone formulation and known to be tolerated before baseline (Day 1). (Even if the patient's experience of taking risperidone or paliperidone cannot be confirmed at the time of informed consent, the patient will be able to meet this criterion if the patient takes oral risperidone 2 mg/day or more or paliperidone ER 6 mg/day or more for at least 4 days between the day of informed consent and the day before baseline, and it is possible to confirm that there is no lack of tolerability in the patient)
- Women of childbearing potential must have a negative ß-human chorionic gonadotropin (ß-hCG) pregnancy test at the screening urine pregnancy test
- Patients must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion
- Primary active DSM-IV-TR Axis I diagnosis other than schizophrenia
- A DSM-IV-TR diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
- Relevant history of or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease
- History or current presence of neuroleptic malignant syndrome or tardive dyskinesia
- Known or suspected hypersensitivity or intolerance to risperidone, paliperidone, or any of their excipients (including egg yolks, soybean oil, phospholipids, and glycerol)
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT01258920
Start Date
October 1 2010
End Date
November 1 2012
Last Update
June 24 2014
Active Locations (29)
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1
Asahi, Japan
2
Fujioka, Japan
3
Fujisawa, Japan
4
Hachiōji, Japan