NCT01362426

Brief Summary

The primary objective of this study is to determine if Australian patients with schizophrenia treated with paliperidone palmitate under conditions of continuous monitoring of outcomes over a 12-month period achieve relapse rates comparable to published literature.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2011

Typical duration for all trials

Geographic Reach
1 country

10 active sites

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

March 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 30, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

2.2 years

First QC Date

May 26, 2011

Last Update Submit

March 9, 2016

Conditions

Schizophrenia

Keywords

schizophreniapaliperidone palmitateINVEGA SUSTENNAregistriesquality of healthcare

Outcome Measures

Primary Outcomes (1)

  • Number of patients with symptomatic relapse

    Up to 12 months

Secondary Outcomes (5)

  • Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: CGI-S.

    Up to 12 months

  • Clinical effectiveness and social outcomes as measured by HoNOS.

    Up to 12 months

  • Clinical effectiveness and social outcomes as measured by PSP.

    Up to 12 months

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Up to 12 months

  • Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: GAF

    Up to 12 months

Study Arms (1)

001

paliperidone palmitate Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.

Drug: paliperidone palmitate

Interventions

paliperidone palmitateDRUG

Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.

001

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Australian patients with schizophrenia will be enrolled in the registry

You may qualify if:

  • Must fulfill the diagnostic criteria for Schizophrenia Disorders as defined by Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM-IV)
  • Must meet the approved Therapeutic Goods Administration (TGA) indication for injectable paliperidone palmitate
  • Must have provided written informed consent indicating that they understand the purpose of and procedures required for the registry and are willing to participate in the registry.

You may not qualify if:

  • Those with a known hypersensitivity to either paliperidone or risperidone, or to any excipients in the paliperidone palmitate formulation
  • Employees of the clinician or study centre, with direct involvement in the proposed registry or other studies under the direction of that clinician or study centre, as well as family members of the employees or the clinician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Bendigo, Australia

Location

Unknown Facility

Box Hill, Australia

Location

Unknown Facility

Elizabeth Vale, Australia

Location

Unknown Facility

Epping, Australia

Location

Unknown Facility

Fitzroy, Australia

Location

Unknown Facility

Fremantle, Australia

Location

Unknown Facility

Glenside, Australia

Location

Unknown Facility

Meadowbrook, Australia

Location

Unknown Facility

Waratah, Australia

Location

Unknown Facility

Wollongong, Australia

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Janssen-Cilag Pty Ltd Clinical Trial

    Janssen-Cilag Pty Ltd

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2011

First Posted

May 30, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 10, 2016

Record last verified: 2016-03

Locations

AU(10)