Study to Measure the Safety of Paliperidone ER (Extended-Release) in Patients With Liver Disease

Condition(s) targeted: Schizoaffective Disorder; Schizophrenia; Psychotic Disorders

Intervention: Treatment as usual (TAU), Paliperidone ER (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Ortho-McNeil Janssen Scientific Affairs, LLC

Official(s) and/or principal investigator(s):
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study Director, Affiliation: Ortho-McNeil Janssen Scientific Affairs, LLC

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

The purpose of this study is to evaluate the tolerability and safety of paliperidone ER (extended-release) in doses between 3 milligrams per day and 12 milligrams per day in the treatment of patients with schizophrenia or schizoaffective disorder and liver disease.

Official title: A Single-Arm Evaluation of the Safety of Paliperidone Extended-Release (ER) in Subjects With Schizophrenia or Schizoaffective Disorder With Hepatic Disease

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Primary outcome: The primary safety outcome of the trial is the difference in the incidence of any adverse events when patients switch their antipsychotic from TAU to paliperidone ER.

Secondary outcome: Various measures of efficacy and safety including PANSS, CGI, MSQ, sleep VAS, SF-36, and PSP will be assessed at different visits throughout the course of the study.

Detailed description: Patients with schizophrenia or schizoaffective disorder commonly have other conditions that may affect the liver, such as alcohol abuse and/or chronic liver infections (hepatitis). Although single-dose studies in patients with liver disease are conducted to test the safety of medications, there is less information about the safety of treatment with medications for schizophrenia in this at-risk population of patients with schizophrenia or schizoaffective disorder and liver disease. This 9-week study is open-label (both patient and investigators know what study drug and dose of study drug the patient is taking) and has 2 phases. During Phase 1, which lasts 4 weeks, patients will continue to take whatever medication they are already taking for schizophrenia (TAU, or treatment as usual). During the first week of Phase 2, patients will receive decreasing doses of TAU and increasing doses of paliperidone ER. For the rest of Phase 2, which lasts 4 more weeks, patients will take paliperidone ER in doses between 3 mg/day and 12 mg/day, as prescribed by the study doctor. This study will evaluate adverse events and will use several scales and tests to measure the effectiveness of paliperidone ER in patients with an established diagnosis of schizophrenia or schizoaffective disorder and liver disease. Study assessments include the PANSS (Positive and Negative Symptom Scale for Schizophrenia), CGI (Clinical Global Impression scale), MSQ (Medication Satisfaction Questionnaire), sleep VAS (Visual Analog Scale), SF-36 (Short Form 36 Health Survey), and PSP (Personal and Social Performance Scale). Each assessment will be performed at least two times during the course of the study, but some assessments will be done more frequently. Visits are scheduled every 1 to two weeks during the 9 week study. The hypothesis is that paliperidone ER can be used safely in patients with schizophrenia or schizoaffective disorder who also have identified liver disease.

During Phase 1 of the study, patients will continue to take whatever medication they are already taking for schizophrenia (TAU, or treatment as usual) for 4 weeks. For the first week of Phase 2, patients will receive decreasing doses of TAU. During Phase 2, patients will take paliperidone ER in doses between 3 milligrams per day and 12 milligrams per day by mouth for 5 weeks.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or

agree to practice an effective method of birth control if they are sexually active before entry and throughout the study, and must also have a negative urine pregnancy test at Screening

- Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis

of schizophrenia or schizoaffective disorder

- Must have identified current, stable liver disease (e. g., viral hepatitis, alcoholic

cirrhosis)

- Child-Pugh class A or B (total score < 10)

Exclusion Criteria:

- Not able to swallow the study medication whole with the aid of water

- Not currently meeting criteria for any other Axis I diagnosis, including a DSM-IV

diagnosis of Bipolar Disorder

- Not using alcohol in the previous 2 weeks or meeting the DSM-IV criteria for substance

abuse or dependence or alcohol abuse or dependence in the 6 months before study entry

- Not experiencing severe liver disease or an acute exacerbation of the underlying liver

disease (Child-Pugh total score >=10)

- No evidence of severe hepatic decompensation within the previous 3 months, such as:

ascites not controlled with diuretics, peritonitis, portal hypertension or gross hepatic encephalopathy (eg, somnolence, stupor, coma)

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

Torrance, California 90502, United States; Recruiting

Huntington Beach, California 92647, United States; Recruiting

Garden Grove, California 92845, United States; Recruiting

Chino, California 91710, United States; Recruiting

Santa Ana, California 92705, United States; Recruiting

Cerritos, California 90703, United States; Recruiting

Kissimmee, Florida 34741, United States; Recruiting

Hollywood, Florida 33021, United States; Recruiting

Fort Lauderdale, Florida 33308, United States; Recruiting

Lake Charles, Louisiana 70601, United States; Recruiting

Flowood, Mississippi 39232, United States; Not yet recruiting

Kansas City, Missouri 64128, United States; Recruiting

Clementon, New Jersey 08021, United States; Recruiting

Albuquerque, New Mexico 87108, United States; Recruiting

Staten Island, New York 10305, United States; Active, not recruiting

Cincinnati, Ohio 45220, United States; Recruiting

Portland, Oregon 97239, United States; Not yet recruiting

Norristown, Pennsylvania 19401, United States; Active, not recruiting

Philadelphia, Pennsylvania 19139, United States; Recruiting

Charleston, South Carolina 29401, United States; Not yet recruiting

Sioux Falls, South Dakota 57105, United States; Recruiting

Irving, Texas 75062, United States; Recruiting

White River Junction, Vermont 05009, United States; Recruiting

To learn how to participate in this trial please click here.

Starting date: October 2007
Ending date: March 2009
Last updated: October 31, 2008