NCT02075528

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. 1.. whether the early prediction model used in other atypicals could also be applied in paliperidone ER.
  2. 2.. The changes of metabolic parameters and pharmacokinetics after paliperidone ER treatment in this study

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Jul 2009

Typical duration for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
Last Updated

March 3, 2014

Status Verified

February 1, 2014

Enrollment Period

2.8 years

First QC Date

February 25, 2014

Last Update Submit

February 27, 2014

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

PaliperidoneTreatment responseSchizophreniaEarly predictionPharmacokinetics

Outcome Measures

Primary Outcomes (1)

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

    Baseline (day 0) and Day 42

Secondary Outcomes (1)

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

    Day 0 and 42

Other Outcomes (1)

  • pharmacokinetic (levels of 9-OH risperidone)

    day 14 and day 42

Study Arms (1)

Paliperidone Extended Release (ER)

EXPERIMENTAL

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

Interventions

Paliperidone ERDRUG

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

Also known as: 9-hydroxyrisperidone
Paliperidone Extended Release (ER)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei City Hospital, Songde Branch

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • MING-CHYI HUANG, M.D., Ph.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2014

First Posted

March 3, 2014

Study Start

July 1, 2009

Primary Completion

May 1, 2012

Study Completion

July 1, 2012

Last Updated

March 3, 2014

Record last verified: 2014-02

Locations

TW(1)