Schizophrenia Clinical Trial
Official title:
A Long-Term, Open-Label Study of Flexibly Dosed Paliperidone Palmitate Long-Acting Intramuscular Injection in Japanese Patients With Schizophrenia
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.
Status | Completed |
Enrollment | 201 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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) |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Pharmaceutical K.K. |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse events as a measure of safety and tolerability | 49 Weeks | Yes | |
Secondary | The change from baseline in Positive and Negative Syndrome Scale (PANSS) total score | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. | Baseline, Week 49 | No |
Secondary | The change from baseline in Clinical Global Impression - Severity (CGI-S) score | The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening. | Baseline, Week 49 | No |
Secondary | Pharmacokinetic evaluations (graphically display to explore dose proportionality and achievement of steady state) | 49 Weeks (Baseline, Week 1, 5, 9, 13, 21, 25, 37, 45, 47 and 49) | No |
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