Background Paliperidone is an active metabolite of risperidone, both of which are
antipsychotic agents for treatment of schizophrenia and related psychotic disorders.
Pharmacogenetic studies have revealed that the efficacy and side effects of antipsychotic
agents are related to polymorphisms of specific genes, however, there are just a few related
studies on paliperidone. The current study aims to evaluate whether pharmacogenetic markers
related to risperidone and genetic markers associated with schizophrenia have effects on the
clinical effectiveness of paliperidone treatment. The study also uses changes of
event-related potentials (ERP) as indices for clinical efficacy.
Methods It is a prospective, open-label, non-randomized and uncontrolled clinical trial to
study the efficacy and side effects of 6-week paliperidone ER treatment for patients with
schizophrenia or schizoaffective disorder. The first three weeks of treatment has to be
inpatient treatment. In the first two weeks, participants will take 9 mg paliperidone ER
daily. Then the dose of paliperidone can be adjusted to within the range of 6-12 mg per day.
Efficacy indicators include symptom severity, global functioning, and ERP. Side effect
indicators include common side effect evaluate, extrapyramidal symptoms, metabolic profiles,
hormonal change, and bone metabolism indices. Participants will also receive examinations for
blood drug concentration, genetic polymorphisms, and epigenetic markers.