Observational Study to Assess Outcomes During Antipsychotic Treatment With Paliperidone ER or Other Oral Antipsychotics

Schizophrenia Clinical Trial

— PILAR  

Official title:

PILAR: Pharmacoepidemiologic International Longitudinal Antipsychotic Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00696813
• Other study ID #: CR014707
• Secondary ID: R076477SCH4016
• Status: Completed
• Phase: Phase 4
• First received: June 5, 2008
• Last updated: February 4, 2013
• Start date: June 2008
• Est. completion date: January 2011

Study information

• Verified date: February 2013
• Source: Janssen-Cilag International NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Observational

Clinical Trial Summary

The purpose of this non-interventional, observational and international registry study is to document the prescribing patterns in daily clinical practice and to assess long term treatment outcomes related to initiation of treatment with oral antipsychotics in a naturalistic setting.

Description:

PILAR is a non-interventional, observational, international registry on the use of oral antipsychotics in a naturalistic setting in patients with schizophrenia. Patients initiating a new oral antipsychotic treatment are candidates for documentation in this registry. All patients should be treated according to local labeling specifications. The overall study objective is to document prescribing patterns in daily clinical practice and to assess long-term treatment outcomes related to initiation of treatment with oral antipsychotics in a naturalistic setting. The primary objective is to prospectively document over one year treatment outcomes and healthcare utilization data that will enable a cost-effectiveness analysis of paliperidone ER compared to other oral antipsychotic treatments. Additional objectives are to retrospectively collect data over one year, which will allow the evaluation of treatment outcomes before and after treatment initiation with paliperidone ER or other oral antipsychotics. Evaluation of Adverse Drug Reactions (ADR) and Serious Adverse Drug Reactions (SADR) for the retrospective period, and Adverse Events (AE) and Serious Adverse Events (SAE) during the prospective period will be performed and reported. Dosing and administration of all treatments should be prescribed at the physician's discretion, and should be based on approved local labels. Dose adjustments or medication changes should be made by the treating physician based on clinical judgment and usual practice. Subjects should receive their medication according to usual care in their treatment setting, and no study drug will be provided. The documentation of the treatment will last one year.

Other known NCT identifiers

• NCT01615133

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3064
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of schizophrenia

• Switch to or start on paliperidone ER or another oral antipsychotic treatment (either atypical or conventional), not longer than 2 weeks ago

• Signed informed consent is available at the beginning of documentation

• Able and willing to fill-out self-administered questionnaires

Exclusion Criteria:

• Established treatment-refractory schizophrenia

• History of neuroleptic malignant syndrome

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag International NV

Countries where clinical trial is conducted

Canada,  Czech Republic,  Denmark,  Kazakhstan,  Sweden,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary treatment duration and time to treatment discontinuation	Primary treatment duration is defined as the time interval (in days) between baseline and stop of the new antipsychotic treatment started at baseline.	Prospective 1-year observation period	No
Secondary	The prospectively documented treatment outcomes also include overall severity of symptoms, personal and social performance, healthcare utilization and health related quality of life and quality of sleep.		12 months	No
Secondary	Use of concomitant medications	Use (Yes/No) of each class of concomitant medications	during a retrospective period of 3 months and at month 3, 6, 9 and 12 after baseline or early discontinuation	No
Secondary	Deterioration of the psychotic condition	A significant deterioration of the psychotic condition is defined as 1 of the following: (a) full hospitalization for exacerbation of psychotic symptoms, (b) need for an increase in level of care, antipsychotic dose increase other than for titration, change in concomitant medication to treat the psychotic symptoms combined with a worsening of psychotic symptoms equivalent to an increase in CGI-S by at least 2 points, (c) deliberate self-injury, (d) emergence of suicidal or homicidal ideation, (e) violent behavior resulting in significant injury to another person or significant property damage	at baseline and at month 3, 6, 9 and 12 after baseline or early discontinuation	No

External Links

•   Pharmacoepidemiologic International Longitudinal Antipsychotic Registry PILAR