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Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier:
NCT01362426
First received: May 26, 2011
Last updated: March 16, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: paliperidone palmitate
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Quality Use of Medicine Clinical Registry to Assess Clinical Outcomes in Patients With Schizophrenia Treated With Intramuscular Injections of Paliperidone Palmitate

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Pty Ltd:

Primary Outcome Measures:
  • Number of patients with symptomatic relapse [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: CGI-S. [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Clinical effectiveness and social outcomes as measured by HoNOS. [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Clinical effectiveness and social outcomes as measured by PSP. [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Clinical effectiveness and social outcomes as measured by the following clinical assessment tools: GAF [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Enrollment: 127
Study Start Date: March 2011
Study Completion Date: May 2013
Groups/Cohorts Assigned Interventions
001
paliperidone palmitate Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.
Drug: paliperidone palmitate
Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Australian patients with schizophrenia will be enrolled in the registry

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362426

Locations
Australia
Bendigo, Australia
Box Hill, Australia
Elizabeth Vale, Australia
Epping, Australia
Fitzroy, Australia
Fremantle, Australia
Glenside, Australia
Meadowbrook, Australia
Waratah, Australia
Wollongong, Australia
Sponsors and Collaborators
Janssen-Cilag Pty Ltd
Investigators
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
  More Information

No publications provided

Responsible Party: Janssen-Cilag Pty Ltd
ClinicalTrials.gov Identifier: NCT01362426     History of Changes
Other Study ID Numbers: CR018013
Study First Received: May 26, 2011
Last Updated: March 16, 2014
Health Authority: Australia: Department of Health
United States: Food and Drug Administration

Keywords provided by Janssen-Cilag Pty Ltd:
schizophrenia
paliperidone palmitate
INVEGA SUSTENNA
registries
quality of healthcare

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
9-hydroxy-risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014