An Exploratory Study on the Safety and Effectiveness of Paliperidone in Patients With Schizophrenia

Sponsor

Janssen Pharmaceutical K.K. (Industry)

Overall Status

Completed

CT.gov ID

NCT00257023

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety, effectiveness, and plasma concentration of paliperidone (an antipsychotic medication) given once daily in the treatment of patients with schizophrenia

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: paliperidone	Phase 2

Detailed Description

Paliperidone is an extended-release tablet. Paliperidone is an active metabolite of risperidone, not approved for the treatment of schizophrenia in Japan. This is a multicenter, open-label, parallel-group, fixed dose study to evaluate the safety, effectiveness, and plasma concentration of paliperidone taken once daily in patients with schizophrenia. The patients will receive a fixed dose of paliperidone (3, 9, and 15 mg) for 6 weeks and its effectiveness and safety will be observed for an additional 2 weeks.. Efficacy will be measured by determining changes throughout the study in the Positive and Negative Syndrome Scale (PANSS) score, a scale for the measurement of symptoms of schizophrenia, and the Clinical Global Impression (CGI) score. In addition, the study also assesses the relationship between dose/plasma drug concentration and dopamine D2 receptor occupancy in patients who consent to receive positron emission tomography (PET). Safety evaluations (symptoms, physical exams, electrocardiograms, laboratory tests, Drug-Induced Extrapyramidal Symptoms Scale [DIESS] results, and adverse event monitoring) will be conducted throughout the study. The study hypothesis is that paliperidone will be effective in the treatment of schizophrenia, and that it will be well-tolerated. The patients will receive either 3, 9, or 15 mg of paliperidone, taken once daily by mouth for 6 weeks.

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Exploratory Study of Paliperidone in Patients With Schizophrenia to Investigate the Safety and Efficacy

Study Start Date :

Feb 1, 2005

Actual Study Completion Date :

Sep 1, 2005

Outcome Measures

Primary Outcome Measures

Safety assessments conducted throughout the study, including adverse events and results from the Drug-Induced Extrapyramidal Symptoms Scale [DIESS] []

Secondary Outcome Measures

Changes measured throughout the study in the Positive and Negative Syndrome Scale (PANSS) score, a score on a scale for the measurement of symptoms of schizophrenia, and the Clinical Global Impression (CGI) score. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV
taking not more than one oral antipsychotic medication within 28 days of study entry
a score below 120 at pre-treatment on the Positive and Negative Syndrome Scale Score (PANSS), a scale for the measurement of symptoms of schizophrenia

Exclusion Criteria:

Diagnosis of psychiatric disease other than schizophrenia according to the diagnostic criteria of DSM-IV
history of Parkinson's disease, seizure disorder, cerebrovascular accident, diabetes mellitus, clinically significant gastrointestinal disorders, or severe impairment of the liver or kidneys
drug allergy or hypersensitivity to antipsychotics