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

NCT ID: NCT02075528

Last Updated: 2014-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2012-07-31

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:

1. . whether the early prediction model used in other atypicals could also be applied in paliperidone ER.

2. . 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paliperidone Extended Release (ER)

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.

Group Type: EXPERIMENTAL

Paliperidone ER

Intervention Type: DRUG

9 mg/d of paliperidone ER was administered during the first 2 weeks, after which the dose was adjusted clinically

Interventions

Paliperidone ER

9 mg/d of paliperidone ER was administered during the first 2 weeks, after which the dose was adjusted clinically

Intervention Type: DRUG

Other Intervention Names

9-hydroxyrisperidone

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Taiwan Ltd

INDUSTRY

Sponsor Role: collaborator

Taipei Institute of Pathology

OTHER_GOV

Sponsor Role: collaborator

Taipei City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MING-CHYI HUANG, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry, Taipei City Hospital, Songde Branch, Taipei, Taiwan

Locations

Taipei City Hospital, Songde Branch

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

EPP-2009-OLS

Identifier Type: -

Identifier Source: org_study_id