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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02075528
• Other study ID #: EPP-2009-OLS
• Status: Completed
• Phase: Phase 4
• First received: February 25, 2014
• Last updated: February 27, 2014
• Start date: July 2009
• Est. completion date: July 2012

Study information

• Verified date: February 2014
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

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

Locations

Country	Name	City	State
Taiwan	Taipei City Hospital, Songde Branch	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
Taipei City Hospital	Johnson & Johnson Taiwan Ltd, Taipei Institute of Pathology

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pharmacokinetic (levels of 9-OH risperidone)		day 14 and day 42	Yes
Primary	Responder: more than 50% improvement on the total score of the Positive and Negative Syndrome Scale (PANSS)		Baseline (day 0) and Day 42	No
Secondary	Metabolic parameters(including lipid profiles, fasting glucose, adiponectin, leptin, and insulin, and prolactin)		Day 0 and 42	Yes