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

Early Prediction of Clinical Response, Metabolic Change, and Pharmacokinetics in Taiwanese Patients With Schizophrenia Patients Treated by Paliperidone ER: an Open-Label Study

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizoaffective Disorder
• Intervention / Treatment: Drug: Paliperidone ER

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Taipei City Hospital, Songde Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Paliperidone ER; 9 mg/d of paliperidone ER was administered during the first 2 weeks, after which the dose was adjusted clinically; Other Names: 9-hydroxyrisperidone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Responder: more than 50% improvement on the total score of the Positive and Negative Syndrome Scale (PANSS)	Baseline (day 0) and Day 42

Secondary Outcome Measures

Outcome Measure	Time Frame
Metabolic parameters(including lipid profiles, fasting glucose, adiponectin, leptin, and insulin, and prolactin)	Day 0 and 42

Other Outcome Measures

Outcome Measure	Time Frame
pharmacokinetic (levels of 9-OH risperidone)	day 14 and day 42

Collaborators and Investigators

• Sponsor: Taipei City Hospital
• Collaborators: Johnson & Johnson Taiwan Ltd; Taipei Institute of Pathology
• Investigators: Principal Investigator: MING-CHYI HUANG, M.D., Ph.D., Department of Psychiatry, Taipei City Hospital, Songde Branch, Taipei, Taiwan

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (ACTUAL): May 1, 2012
• Study Completion (ACTUAL): July 1, 2012

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: February 27, 2014
• First Posted (ESTIMATE): March 3, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): March 3, 2014
• Last Update Submitted That Met QC Criteria: February 27, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Schizophrenia; Pharmacokinetics; Paliperidone; Treatment response; Early prediction
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Paliperidone Palmitate
• Other Study ID Numbers: EPP-2009-OLS