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

Phase 4

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: Paliperidone ER

• Registration Number: NCT02075528
• Lead Sponsor: Taipei City Hospital

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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2012-05
• Study Completion: 2012-07
• Status Verified: 2014-02
• Study First Submitted: 2014-02-25
• Study First Submitted QC: 2014-02-27
• Last Update Submitted: 2014-02-27
• Study First Posted: 2014-03-03
• Last Update Posted: 2014-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paliperidone Extended Release (ER)	Paliperidone 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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Metabolic parameters(including lipid profiles, fasting glucose, adiponectin, leptin, and insulin, and prolactin)	Day 0 and 42

Trial Locations

Locations (1)

Taipei City Hospital, Songde Branch; 🇨🇳 Taipei, Taiwan