Paliperidone Palmitate Effectiveness Assessment Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

127 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-05-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Schizophrenia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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001

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

paliperidone palmitate

Intervention Type DRUG

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

Interventions

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paliperidone palmitate

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No