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A Pharmacokinetic Study of Paliperidone ER

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ClinicalTrials.gov Identifier: NCT02433717
Recruitment Status : Unknown
Verified November 2015 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : May 5, 2015
Last Update Posted : November 23, 2015
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Paliperidone ER Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study on the Efficacy, Pharmacokinetics and Adverse Effects of Paliperidone ER
Study Start Date : April 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Paliperidone ER
Six-week paliperidone ER
Drug: Paliperidone ER
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.
Other Name: Invega




Primary Outcome Measures :
  1. Pharmacodynamics factor on response rate [ Time Frame: day 42 ]

    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%


  2. Pharmacogenetic factor on response rate: ABCB1 [ Time Frame: day 42 ]
    Whether 1236C/T of the ABCB1 gene is associated with the clinical response rate on day 42.

  3. Pharmacogenetic factor on response rate: DRD3 [ Time Frame: day 42 ]
    Whether Ser9Gly of the DRD3 gene is associated with the clinical response rate on day 42.

  4. Pharmacogenetic factor on response rate: DRD2 [ Time Frame: day 42 ]
    Whether Ser311Cys of the DRD2 gene is associated with the clinical response rate on day 42.

  5. Pharmacogenetic factor on response rate: 5HTR6 [ Time Frame: day 42 ]
    Whether 267T/C of the 5HTR6 gene is associated with the clinical response rate on day 42.

  6. Pharmacogenetic factor on response rate: 5HTR2A [ Time Frame: day 42 ]
    Whether 102T/C of the 5HTR2A gene is associated with the clinical response rate on day 42.

  7. Pharmacogenetic factor on response rate: 5HTR2C [ Time Frame: day 42 ]
    Whether 995G/A of the 5HTR2C gene is associated with the clinical response rate on day 42.

  8. Pharmacogenetic factor on response rate: BDNF [ Time Frame: day 42 ]
    Whether dinucleotide repeat (GT)n of the BDNF gene is associated with the clinical response rate on day 42.

  9. Pharmacogenetic factor on response rate: COMT [ Time Frame: day 42 ]
    Whether val108/158Met of the COMT gene is associated with the clinical response rate on day 42.

  10. Pharmacogenetic factor on response rate: RGS4 [ Time Frame: day 42 ]
    Whether polymorphisms of RGS4 gene is associated with the clinical response rate on day 42.


Secondary Outcome Measures :
  1. Change in person and social function [ Time Frame: day 4, day 7, day14, day 28, and day 42 ]
    Measured by Personal and Social Performance Scale (PSP)

  2. Change in global impression of the patient [ Time Frame: day 4, day 7, day14, day 28, and day 42 ]
    Measured by Clinical Global Impression-Severity (CGI-S) 2. Side effect variables: DIEPSS, UKU side effect scales, body weight, blood chemistry markers, metabolic markers, hormonal markers, and bone turnover markers

  3. Change in mismatch negativity [ Time Frame: day 42 ]
    Mismatch negativity is an event-related potential measurement

  4. Change in P50 [ Time Frame: day 42 ]
    P50 is an event-related potential measurement

  5. Change in auditory steady state response [ Time Frame: day 42 ]
    Auditory steady state response is an event-related potential measurement

  6. Change in attention as measured by Continuous Performance Test (CPT) [ Time Frame: day 42 ]
    CPT is a neurocognitive test

  7. Change in executive function as measured by Wisconsin Card Sorting Test (WCST) [ Time Frame: day 42 ]
    WCST is a neurocognitive test

  8. Change in performance on Trail-A test [ Time Frame: day 42 ]
    Trail-A test is a neurocognitive test

  9. Change in performance on Trail-B test [ Time Frame: day 42 ]
    Trail-B test is a neurocognitive test

  10. Change in performance on verbal fluency test [ Time Frame: day 42 ]
    Verbal fluency test is a neurocognitive test

  11. Change in performance on Digit Span [ Time Frame: day 42 ]
    Digit Span is a subtest of Wechsler Adult Intelligence Test-III

  12. Change in performance on Arithmetic [ Time Frame: day 42 ]
    Arithmetic is a subtest of Wechsler Adult Intelligence Test-III

  13. Pharmacodynamics and pharmacogenetics factors on response rate [ Time Frame: day 4, day 7, day14, day 28 ]

    Clinical response are defined as 50% or more improvement in terms of PANSS total score:

    [(PANSS at evaluation - PANSS at baseline)/ (PANSS at baseline - 30)]*100% ≥ 50%


  14. Severity of extrapyramidal symptoms [ Time Frame: day 4, day 7, day14, day 28, day 42 ]
    Severity of extrapyramidal symptoms is measured by Drug-Induced Extrapyramidal Symptom Scale (DIEPSS)

  15. Severity of side effects [ Time Frame: day 4, day 7, day14, day 28, day 42 ]
    Severity of side effects is measured by Udvalg for Kliniske Undersogelser (UKU) Side Effect Rating Scale

  16. Effects on blood glucose level [ Time Frame: day 14 and day 42 ]
    AC sugar

  17. Effects on blood cholesterol level [ Time Frame: day 14 and day 42 ]
  18. Effects on blood triglyceride level [ Time Frame: day 14 and day 42 ]
  19. Effects on blood HDL-cholesterol level [ Time Frame: day 14 and day 42 ]
  20. Effects on blood prolactin level [ Time Frame: day 14 and day 42 ]
  21. Effects on blood leptin level [ Time Frame: day 14 and day 42 ]
  22. Effects on adiponectin level [ Time Frame: day 14 and day 42 ]
  23. Effects on blood alkaline phosphatase level [ Time Frame: day 42 ]
  24. Effects on blood calcium level [ Time Frame: day 42 ]
  25. Effects on blood phosphate level [ Time Frame: day 42 ]
  26. Effects on blood bone-specific alkaline phosphatase level [ Time Frame: day 42 ]
  27. Effects on blood intact osteocalcin level [ Time Frame: day 42 ]
  28. Effects on blood oestradiol level [ Time Frame: day 42 ]
  29. Effects on blood progesterone level [ Time Frame: day 42 ]
  30. Effects on blood LH level [ Time Frame: day 42 ]
  31. Effects on blood FSH level [ Time Frame: day 42 ]
  32. Effects on blood testosterone level [ Time Frame: day 42 ]
  33. Effects on blood uric acid level [ Time Frame: day 14 and day 42 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02433717


Contacts
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Contact: Yi-Ting Lin +886-972-653-797 p98421013@ntu.edu.tw

Locations
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Taiwan
Department of Psychiatry, National Taiwan University Hospital Not yet recruiting
Taipei, Test2, Taiwan, test3
Contact: Yi-Ting Lin    +886-972-653-797    p98421013@ntu.edu.tw   
Sub-Investigator: Ming H. Hsieh         
Sub-Investigator: Yi-Lin Chien         
Sub-Investigator: Chih-Min Liu         
Sub-Investigator: Tzung-Jeng Hwang         
Sub-Investigator: Chen-Chung Liu         
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Yi-Ting Lin, MD    +886-2-23123456 ext 67990    p98421013@ntu.edu.tw   
Principal Investigator: Yi-Ting Lin, MD         
Sub-Investigator: Chin-Min Liu, MD, PhD         
Sub-Investigator: Ming H Hsieh, MD, PhD         
Sub-Investigator: Tzung-Jeng Hwang, MD, PhD         
Sub-Investigator: Chen-Chung Liu, MD, PhD         
Principal Investigator: Yi-Ling Chien, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Yi-Ting Lin National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02433717     History of Changes
Other Study ID Numbers: 201501049MINC
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: November 23, 2015
Last Verified: November 2015

Keywords provided by National Taiwan University Hospital:
schizophrenia
schizoaffective disorder
pharmacogenetics
pharmacokinetics
event-related potentials
paliperidone

Additional relevant MeSH terms:
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Paliperidone Palmitate
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents