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Completed

NCT Number: NCT01362426

Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL)

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bendigo, Australia

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About this study

This study involves the establishment of PEARL, an Australian Quality Use of Medicine clinical registry designed to collect clinical and social data on up to 300 patients with schizophrenia for a 12-month period after initiating treatment with intramuscular (IM) injections of paliperidone palmitate as part of their routine clinical care. Continuous feedback of clinical outcomes will be via regular reports to all registry sites. Enrollment in PEARL should be considered only after the clinical decision to prescribe IM paliperidone palmitate has already been made because the treating physician has determined that this treatment is the best option for the patient. Observational Study - No investigational drug administered

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Paliperidone palmitate

Drug

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

Primary outcomes

  1. Number of patients with symptomatic relapse

    Time frame: Up to 12 months

Secondary outcomes

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

    Time frame: Up to 12 months

  2. Clinical effectiveness and social outcomes as measured by HoNOS.

    Time frame: Up to 12 months

  3. Clinical effectiveness and social outcomes as measured by PSP.

    Time frame: Up to 12 months

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

    Time frame: Up to 12 months

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

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Janssen-Cilag Pty Ltd

Industry

Registry information

Official study title

A Quality Use of Medicine Clinical Registry to Assess Clinical Outcomes in Patients With Schizophrenia Treated With Intramuscular Injections of Paliperidone Palmitate

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 30, 2011
Registry last updated
Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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