A Pharmacokinetic Study of Paliperidone ER

• Status: Unknown status
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Paliperidone Palmitate

Criteria

Inclusion criteria:

• 20-65 years old

• With DSM-IV diagnosis of schizophrenia or schizoaffective disorder

• Being hospitalized in an acute psychiatric ward

• Scoring at least 60 according to the Positive and Negative Syndrome Scale (PANSS)

• Having not received long-acting injectable antipsychotics in the past 6 months

• Having no major physical disorders or significant abnormalities in laboratory studies

Exclusion criteria:

• Having abused illicit substances in the past 6 months

• Having physical disorders that may influence the absorption, metabolism, or excretion of paliperidone ER

• With substantial suicidal or violence risk

• Being pregnant or lactating, or with high probability of getting pregnant

• With other significant central nervous system abnormalities

• With other significant unstable or incurable physical illnesses

• Having ever taken clozapine in the past 3 months

• Having ever taken paliperidone ER within 30 days before eligibility evaluation

• History of allergy to paliperidone ER or risperidone

• Without the competence to sign the informed consent

• Hearing impairments