The Paliperidone ER Observational Study of Economic, Functional, and Clinical Outcomes in Patients With Schizophrenia (POST)
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|ClinicalTrials.gov Identifier: NCT00488891|
Recruitment Status : Terminated (The study was terminated because it was not enrolling at the expected rate)
First Posted : June 20, 2007
Last Update Posted : August 29, 2012
|Condition or disease||Intervention/treatment|
|Schizophrenia||Drug: Paliperidone ER Drug: Atypical antipsychotics (AAP)|
|Study Type :||Observational|
|Actual Enrollment :||43 participants|
|Official Title:||The Paliperidone ER Outcomes Study of Schizophrenia Patients in Typical Clinical Practice|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
Paliperidone extended release (ER)
Drug: Paliperidone ER will be prescribed to the patients at the investigator's discretion. Patient receive their medication according to usual care in their treatment setting ie, no study drug is provided
Drug: Paliperidone ER
Route = oral. Paliperidone ER will be prescribed to the patients at the investigator's discretion. Patient receive their medication according to usual care in their treatment setting ie, no study drug is provided
Other Name: Invega
Atypical antipsychotics agent (AAP)
AAP includes quetiapine, risperidone, olanzapine, ziprasidone or aripiprazole. Dosage and administration of antipsychotics will be prescribed at the investigator's discretion
Drug: Atypical antipsychotics (AAP)
Route = oral. AAP including quetiapine, risperidone, olanzapine, ziprasidone or aripiprazole. Dosage and administration of antipsychotics will be prescribed at the investigator's discretion
- Changes in the yearly rate of hospital admissions before and after treatment with paliperidone extended release (ER) [ Time Frame: 12 months before and post baseline ]The baseline is referred to month 0; Baseline is the time when patients are initiated on paliperidone ER or on any other oral atypical antipsychotics [AAP]).
- Change from baseline in Clinical Global Impression of the severity (CGI-S) scale [ Time Frame: Baseline to Month 12 ]This scale measures global severity of illness at a given point in time. Treating physician rates the severity of a patients condition on a seven-point scale ranging from 1 (no symptoms) to 7 (very severe).
- Change from baseline in Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline to Month 12 ]This is a 30-item scale that was designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology).
- Change from baseline in Personal and Social Performance Scale (PSP and SF-36) [ Time Frame: Baseline to Month 12 ]The PSP is a clinician-based rating instrument providing an overall rating of personal and social functioning in psychiatric patients on a scale of 0 (grossly impaired functioning) to 100 (excellent functioning).
- Change from baseline in Independent Living Skills Survey (ILSS) [ Time Frame: Baseline to Month 12 ]It is a measure of basic functional and cognitive skills of individuals that was developed and validated for use in severe and persistent mental illness including schizophrenia. These include taking care of one's personal appearance, money, possessions, residence, and health; finding and keeping a job and interacting with others.
- Change from baseline in Healthcare and Social Services Resource Utilization [ Time Frame: Baseline to Month 12 ]Resource utilization includes healthcare and social services such as inpatient and outpatient hospital use, emergency room visits, and crisis team interventions.
- Relapse rate [ Time Frame: Baseline to Month 12 ]Relapse is defined as: 1) Psychiatric hospitalization due to worsening symptomatology (not for social reason) 2) Deliberate self-injury, suicidal or homicidal ideation 3) Violent behaviour resulting in clinically significant injury to another person or property damage 4) An increase in the level of psychiatric care (eg, from clinic visits to day treatment) and substantial clinical deterioration, defined as a change score of 6 ("much worse") or 7 ("very much worse") on the clinicla global impression of change scale (CGI-C).
- Change from baseline in Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Baseline and Month 12 ]This is a valid and reliable method of screening for tardive dyskinesia (disorder resulting in involuntary, repetitive body movements). It measures facial, oral, extremity and trunk movements as well as the patients awareness of abnormal movements. The AIMS contains 10 items on a scale from 0 (none) to 4 (severe). In addition, there are 2 items on dental status that are answered "yes" or "no."
- Change from baseline in Clinical Global Impression of change scale (CGI-C) [ Time Frame: Month 3 to Month 12 ]The CGI-C measures change from the baseline state. The treating physician assesses the patient's clinical change relative to the symptoms at baseline on a seven-point scale, ranging from 1 (very much improved) to 7 (very much worse).
- Change from baseline in Short-Form 36 Health Survey (SF-36) [ Time Frame: Baseline to Month 12 ]The SF-36 is a well-validated and widely used quality of life instrument. It is a self-administered survey that measures eight domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health.
- Change from baseline in Medication Compliance with Antipsychotic Medication [ Time Frame: Baseline to Month 12 ]Compliance with antipsychotic medication will be documented by the investigator or designee. Compliance will be broadly categorized as always compliant, partially compliant, or never compliant.
- Change from baseline in Patient Satisfaction with Antipsychotic Medication [ Time Frame: Baseline to Month 12 ]Antipsychotic Medication Satisfaction Question is assessed by a single, self-administered seven-point Likert-type question with anchor points of extremely dissatisfied, very dissatisfied, somewhat dissatisfied, neither satisfied nor dissatisfied, somewhat satisfied, very satisfied, and extremely satisfied.
- Changes in safety parameters [ Time Frame: Baseline to Month 12 ]Safety parameters include treatment-emergent adverse experiences and serious adverse experiences, physical exam, monitoring of weight, vital signs, blood glucose, hemoglogin A1C, lipid panel, and regular monitoring of movement disorders via the AIMS
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488891
|Study Director:||Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial||Ortho-McNeil Janssen Scientific Affairs, LLC|