A Study of Paliperidone Palmitate in Japanese Patients With Schizophrenia

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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: explore the efficacy on symptoms of schizophrenia and the maintenance of treatment effect; explore the pharmacokinetics of paliperidone palmitate through sparse pharmacokinetic sampling.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)