A Study of Paliperidone Blood Concentrations in Patients With Schizophrenia After Administration of Paliperidone Palmitate

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the concentration of paliperidone in the blood after intramuscular injection in upper arm (deltoid muscle) or in the buttock (gluteal muscle) in patients with schizophrenia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Have a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for more than 1 year that is clinically stable with no change in current antipsychotic medications for 3 months prior to screening

• Have a total Positive and Negative Syndrome Scale for Schizophrenia (PANSS) score of 70 or less, a score of no more than 16 points on the sum of the following 4 items of the PANSS: conceptual disorganization, suspiciousness/persecution, hallucinatory behavior, and unusual thought content, and scores not greater than 5 on any of the individual items of the PANSS

• Be otherwise healthy confirmed by prestudy physical examination, 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory tests

• Sign an informed consent document indicating an understanding of the purpose and procedures required for the study and a willingness to participate in the study

Exclusion Criteria:

• Have a DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence, within 12 months prior to screening

• Be involuntarily-hospitalized or plan to undergo surgery/procedures during the course of the study

• Take the following prohibited medications: oral risperidone within 2 weeks of randomization, oral paliperidone within 2 weeks of randomization with the exception of the tolerability testing period, clozapine therapy within 6 weeks of randomization, use of ziprasidone and thioridazine within 1 week prior to randomization, risperidone within 100 days of screening, a paliperidone palmitate long-acting preparation within 10 months of randomization, long-acting formulations of other neuroleptic drugs within 1 treatment cycle before screening, barbiturates within 14 days prior to randomization, any anticonvulsant medications within 14 days prior to randomization, or use of irbesartan within 1 week prior to randomization

• Have a history of an allergic reaction to risperidone, paliperidone, or any of their excipients, or have a known hypersensitivity to risperidone or paliperidone

• Have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening