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Early Prediction of Clinical Response in Patients With Schizophrenia Treated by Paliperidone ER

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Paliperidone ER
Sponsored by
Taipei City Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Paliperidone, Treatment response, Schizophrenia, Early prediction, Pharmacokinetics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
  • a minimal baseline total score of 60 on the PANSS
  • those who had not received long-acting antipsychotic injection for the preceding 6 months
  • physically healthy and standard clinical laboratory test results within laboratory reference ranges, or if outside the ranges, judged to be clinically insignificant by the investigators.

Exclusion Criteria:

  • diagnosis of substance (including alcohol) dependence in the previous 6 months
  • a medical condition that could affect absorption, metabolism, or excretion of the study drug
  • substantial risk of suicide or violent behavior
  • pregnancy or breastfeeding
  • documented organic disease of the central nervous system
  • unstable or critical untreated medical illness
  • history of clozapine treatment in the previous 3 months
  • participation in an investigational drug trial in the 30 days before screening.

Sites / Locations

  • Taipei City Hospital, Songde Branch

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paliperidone Extended Release (ER)

Arm Description

The participants were assigned to receive a fixed dosage of 9 mg/d of paliperidone ER for the first 2 weeks. The paliperidone ER dosage was adjusted flexibly after 2 weeks according to the clinical judgment of the physicians in charge.

Outcomes

Primary Outcome Measures

Responder: more than 50% improvement on the total score of the Positive and Negative Syndrome Scale (PANSS)

Secondary Outcome Measures

Metabolic parameters(including lipid profiles, fasting glucose, adiponectin, leptin, and insulin, and prolactin)

Full Information

First Posted
February 25, 2014
Last Updated
February 27, 2014
Sponsor
Taipei City Hospital
Collaborators
Johnson & Johnson Taiwan Ltd, Taipei Institute of Pathology
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1. Study Identification

Unique Protocol Identification Number
NCT02075528
Brief Title
Early Prediction of Clinical Response in Patients With Schizophrenia Treated by Paliperidone ER
Official Title
Early Prediction of Clinical Response, Metabolic Change, and Pharmacokinetics in Taiwanese Patients With Schizophrenia Patients Treated by Paliperidone ER: an Open-Label Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei City Hospital
Collaborators
Johnson & Johnson Taiwan Ltd, Taipei Institute of Pathology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Paliperidone ER is a new psychotropic medication for schizophrenia treatment. The studies of 6-week acute treatment and 52-week maintenance treatment showed positive results in patients with schizophrenia and its clinical improvement may start at Day 4. Some second-generation antipsychotics have been found that using the first 2 weeks' treatment results to predict the fourth or sixth week's treatment response is acceptable. The primary aim of this study is to investigate: . whether the early prediction model used in other atypicals could also be applied in paliperidone ER. . The changes of metabolic parameters and pharmacokinetics after paliperidone ER treatment in this study
Detailed Description
Patients diagnosed with schizophrenia or schizoaffective disorders will be enrolled in the 6-week trial. Eligible patients will receive 9mg paliperidone ER first. Then, the dosage of paliperidone could be adjusted two weeks later according to clinical judgement. They will be followed and receive assessment of pharmacokinetics, metabolic parameters ( lipid profiles, glucose, insulin, adiponectin, leptin, and prolactin, etc.), and the treatment response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Paliperidone, Treatment response, Schizophrenia, Early prediction, Pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paliperidone Extended Release (ER)
Arm Type
Experimental
Arm Description
The participants were assigned to receive a fixed dosage of 9 mg/d of paliperidone ER for the first 2 weeks. The paliperidone ER dosage was adjusted flexibly after 2 weeks according to the clinical judgment of the physicians in charge.
Intervention Type
Drug
Intervention Name(s)
Paliperidone ER
Other Intervention Name(s)
9-hydroxyrisperidone
Intervention Description
9 mg/d of paliperidone ER was administered during the first 2 weeks, after which the dose was adjusted clinically
Primary Outcome Measure Information:
Title
Responder: more than 50% improvement on the total score of the Positive and Negative Syndrome Scale (PANSS)
Time Frame
Baseline (day 0) and Day 42
Secondary Outcome Measure Information:
Title
Metabolic parameters(including lipid profiles, fasting glucose, adiponectin, leptin, and insulin, and prolactin)
Time Frame
Day 0 and 42
Other Pre-specified Outcome Measures:
Title
pharmacokinetic (levels of 9-OH risperidone)
Time Frame
day 14 and day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) a minimal baseline total score of 60 on the PANSS those who had not received long-acting antipsychotic injection for the preceding 6 months physically healthy and standard clinical laboratory test results within laboratory reference ranges, or if outside the ranges, judged to be clinically insignificant by the investigators. Exclusion Criteria: diagnosis of substance (including alcohol) dependence in the previous 6 months a medical condition that could affect absorption, metabolism, or excretion of the study drug substantial risk of suicide or violent behavior pregnancy or breastfeeding documented organic disease of the central nervous system unstable or critical untreated medical illness history of clozapine treatment in the previous 3 months participation in an investigational drug trial in the 30 days before screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MING-CHYI HUANG, M.D., Ph.D.
Organizational Affiliation
Department of Psychiatry, Taipei City Hospital, Songde Branch, Taipei, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei City Hospital, Songde Branch
City
Taipei
ZIP/Postal Code
110
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Early Prediction of Clinical Response in Patients With Schizophrenia Treated by Paliperidone ER

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