Schizophrenia with Hepatic Disease Study
Principal Investigator: S. Pirzada Sattar, MD
Study Coordinator: Christi Hinker, RNC
Sub-Investigators: William C. Fuller, MD; Julie M. Kittelsrud, CNP; Susan E. Weaver, CNP
Study Description: A Single-Arm Evaluation of the Safety of Paliperidone Extended-Release (ER) in Subjects with Schizophrenia or Schizoaffective Disorder with Hepatic Disease
Overview: The purpose of this clinical drug study is to evaluate the safety and tolerability of Paliperidone ER in individuals with liver disease and also have been diagnosed with schizophrenia or schizoaffective disorder. Overall, this study will compare safety while participants are on their current antipsychotic medications to safety while they are on Paliperidone ER.
Paliperidone ER has received approval from the U.S. Food & Drug Administration for the treatment of schizophrenia; the use of the medication for the treatment of schizoaffective disorder is investigational and has not been approved by the U.S. Food & Drug Administration.
Participation in this study is expected to last approximately 9 weeks, with about 8 study clinic visits during that time. Required procedures, such as a physical examination, laboratory evaluations and an EKC, will be provided to the subject at no cost. The investigational medication will be provided at no cost, but participants are responsible for providing and paying for their current medications. Participants will be compensated for their time and travel.
Inclusion Criteria:
Exclusion Criteria:
- Women who are pregnant, breast feeding or planning to become pregnant
- Alcohol use within 2 weeks prior to entering the study or alcohol or substance abuse/dependence in the 3 months prior to entering the study
- History of violence or at imminent risk of suicide or harming self or others
- History of seizure disorder or head injury
Contact: Christi Hinker , RNC
Phone: (605) 322-3084
Email: christi.hinker@mckennan.org
