Schizophrenia Clinical Trial
Official title:
Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Subjects With Schizophrenia
The purpose of this study is to evaluate the pharmacokinetics (study of what the body does to a drug) and safety of paliperidone palmitate ranging from 75 to 150 milligram equivalents in repeated doses (4 injections) administered in the deltoid muscle (muscle in the shoulder) or gluteal muscle (group of muscles present in the buttocks) in participants with schizophrenia.
Status | Completed |
Enrollment | 76 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 65 Years |
Eligibility |
Inclusion Criteria:- Participants had to have the capability to provide informed consent
in writing to participate in the study - Participants with a diagnosis of schizophrenia in accordance with the diagnostic criteria for Diagnostic and Statistical Manual of Mental Disorders -IV-TR (DSM-IV-TR) - Participants whose psychiatric symptom is considered stable by the investigator/subinvestigator at the time of giving informed consent - Participants with a Positive and Negative Syndrome Scale (PANSS) score of less than or equal to 4 (moderate) in the following 9 items at screening: delusion, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility, uncooperativeness, poor impulse control - Participants with an experience of taking a risperidone formulation or a paliperidone formulation by 8 days before the initial day (Day 1) of the study treatment Exclusion Criteria:- DSM-IV-TR diagnosis other than schizophrenia - DSM-IV-TR diagnosis of substance-related disorders within 180 days before the date of screening - At a risk of suicide or other-injurious behavior as considered by the investigator/subinvestigator , and participants with a history of suicide attempts - Concurrent condition of Parkinson's disease (except for drug-induced extrapyramidal syndrome) - Concurrent condition or history of symptomatic cerebrovascular accident |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen Pharmaceutical K.K. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma concentration of unchanged drug (Paliperidone palmitate) | Days 1 to 190 | No | |
Primary | Plasma concentration of active metabolite (paliperidone) | Days 1 to 190 | No | |
Primary | Plasma concentration of enantiomer of paliperidone palmitate (R078543) | Days 1 to 190 | No | |
Primary | Plasma concentration of enantiomer paliperidone palmitate (R078544) | Days 1 to 190 | No | |
Primary | Maximum Observed Plasma Concentration (Cmax) of paliperidone palmitate | The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration. | Days 1 to 190 | No |
Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of paliperidone palmitate | The Tmax is defined as actual sampling time to reach maximum observed analyte concentration. | Days 1 to 190 | No |
Primary | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of paliperidone palmitate | The Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) is a measure of the plasma paliperidone concentration from time zero to end of dosing interval. It is used to characterize drug absorption. | Days 1 to 190 | No |
Primary | Number of participants with adverse events | Up to Day 190 | Yes | |
Secondary | Change from baseline in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) | The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening. | Screening, Baseline (Day 1), Days 8, 36, 64, and 92 | No |
Secondary | Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale 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 participant. 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 participants". Higher scores indicate worsening. | Screening, Baseline (Day 1), Days 8, 36, 64, and 92 | No |
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