A Pharmacokinetic Study of Paliperidone ER

NCT02433717 | Unknown Phase 4 DMC

• 1 other identifier: 201501049MINC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

schizophrenia; schizoaffective disorder; pharmacogenetics; pharmacokinetics; event-related potentials; paliperidone

Outcome Measures

Primary Outcomes (10)

• Pharmacodynamics factor on response rate

  Whether the concentration of blood paliperidone is related to the clinical response rate on day 42. Clinical response is defined as achieving 50% or more improvement in terms of PANSS total score: \[(PANSS at evaluation - PANSS at baseline)/ (PANSS at baseline - 30)\]\*100% ≥ 50%

  day 42

• Pharmacogenetic factor on response rate: ABCB1

  Whether 1236C/T of the ABCB1 gene is associated with the clinical response rate on day 42.

  day 42

• Pharmacogenetic factor on response rate: DRD3

  Whether Ser9Gly of the DRD3 gene is associated with the clinical response rate on day 42.

  day 42

• Pharmacogenetic factor on response rate: DRD2

  Whether Ser311Cys of the DRD2 gene is associated with the clinical response rate on day 42.

  day 42

• Pharmacogenetic factor on response rate: 5HTR6

  Whether 267T/C of the 5HTR6 gene is associated with the clinical response rate on day 42.

  day 42

• Pharmacogenetic factor on response rate: 5HTR2A

  Whether 102T/C of the 5HTR2A gene is associated with the clinical response rate on day 42.

  day 42

• Pharmacogenetic factor on response rate: 5HTR2C

  Whether 995G/A of the 5HTR2C gene is associated with the clinical response rate on day 42.

  day 42

• Pharmacogenetic factor on response rate: BDNF

  Whether dinucleotide repeat (GT)n of the BDNF gene is associated with the clinical response rate on day 42.

  day 42

• Pharmacogenetic factor on response rate: COMT

  Whether val108/158Met of the COMT gene is associated with the clinical response rate on day 42.

  day 42

• Pharmacogenetic factor on response rate: RGS4

  Whether polymorphisms of RGS4 gene is associated with the clinical response rate on day 42.

  day 42

Secondary Outcomes (33)

• Change in person and social function

  day 4, day 7, day14, day 28, and day 42

• Change in global impression of the patient

  day 4, day 7, day14, day 28, and day 42

• Change in mismatch negativity

  day 42

• Change in P50

  day 42

• Change in auditory steady state response

  day 42

Study Arms (1)

Paliperidone ER

EXPERIMENTAL

Six-week paliperidone ER

Drug: Paliperidone ER

Interventions

Paliperidone ER DRUG

Fixed dose (9 mg/day) of paliperidone ER will be given in the first two weeks of trial (from day 1 to day 14). Since the third week (day 15), the dosage can be adjusted in the range of 6 to 12 mg per day.

Also known as: Invega

Paliperidone ER

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

RECRUITING

Department of Psychiatry, National Taiwan University Hospital

Taipei, Test2, test3, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Yi-Ting Lin

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Ting Lin

CONTACT

+886-972-653-797; p98421013@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: May 5, 2015
• Study Start: April 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: November 23, 2015

Record last verified: 2015-11

Locations

TW (2)