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

May 26, 2011
March 16, 2014
March 2011
Not Provided
Number of patients with symptomatic relapse [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01362426 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL)
A Quality Use of Medicine Clinical Registry to Assess Clinical Outcomes in Patients With Schizophrenia Treated With Intramuscular Injections of Paliperidone Palmitate

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.

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

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Australian patients with schizophrenia will be enrolled in the registry

Schizophrenia
Drug: paliperidone palmitate
Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.
001
paliperidone palmitate Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.
Intervention: Drug: paliperidone palmitate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
May 2013
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01362426
CR018013
Not Provided
Janssen-Cilag Pty Ltd
Janssen-Cilag Pty Ltd
Not Provided
Study Director: Janssen-Cilag Pty Ltd Clinical Trial Janssen-Cilag Pty Ltd
Janssen-Cilag Pty Ltd
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP