Clinical trial NCT01362426: Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL)
Official title: A Quality Use of Medicine Clinical Registry to Assess Clinical Outcomes in Patients With Schizophrenia Treated With Intramuscular Injections of Paliperidone Palmitate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: schizophrenia
paliperidone palmitate
INVEGA SUSTENNA
registries
quality of healthcare
Lead sponsor: Janssen-Cilag Pty Ltd
Sponsor class: INDUSTRY
First posted: 2011-05-30
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Australian patients with schizophrenia will be enrolled in the registry

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.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with symptomatic relapse
timeFrame: Up to 12 months
Secondary outcomes:
measure: Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: CGI-S.
timeFrame: Up to 12 months
measure: Clinical effectiveness and social outcomes as measured by HoNOS.
timeFrame: Up to 12 months
measure: Clinical effectiveness and social outcomes as measured by PSP.
timeFrame: Up to 12 months
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 12 months
measure: Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: GAF
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Bendigo
country: Australia
city: Box Hill
country: Australia
city: Elizabeth Vale
country: Australia
city: Epping
country: Australia
city: Fitzroy
country: Australia
city: Fremantle
country: Australia
city: Glenside
country: Australia
city: Meadowbrook
country: Australia
city: Waratah
country: Australia
city: Wollongong
country: Australia
Study officials:
affiliation: Janssen-Cilag Pty Ltd
name: Janssen-Cilag Pty Ltd Clinical Trial
role: STUDY_DIRECTOR
References: