The Paliperidone ER Observational Study of Economic, Functional, and Clinical Outcomes in Patients With Schizophrenia (POST)

This study has been terminated.
(The study was terminated because it was not enrolling at the expected rate)
Sponsor:
Information provided by (Responsible Party):
Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier:
NCT00488891
First received: June 18, 2007
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to examine the long-term economic, functional and clinical outcomes in schizophrenia patients who require a change in antipsychotic treatment, and are changed to either paliperidone extended release (ER) or another oral atypical antipsychotic agent (AAP) including aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone ER
Drug: Atypical antipsychotics (AAP)
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Paliperidone ER Outcomes Study of Schizophrenia Patients in Typical Clinical Practice

Resource links provided by NLM:


Further study details as provided by Ortho-McNeil Janssen Scientific Affairs, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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]).


Secondary Outcome Measures:
  • Change from baseline in Clinical Global Impression of the severity (CGI-S) scale [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

10 mL blood sample is collected from patients who consent to the pharmacogenomic component of the study.


Enrollment: 43
Study Start Date: April 2007
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

This is a 12-month, retrospective (a study that looks backward in time, usually using medical records and interviews with patients who are already known to have a disease)/prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), open-label (all people involved know the identity of the assigned drug) study of clinical, functional and economic outcomes in schizophrenia patients who require a change in antipsychotic treatment. The patients will be randomly (study drug assigned by chance like flipping a coin) assigned to receive either paliperidone extended release (ER) or one of two other prescriber-selected oral atypical antipsychotic (AAPs). The AAPs include aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone. Baseline will be defined as the time when the patient begins to take paliperidone ER or the other AAP. The study has a "pre/post" design in which paliperidone ER patients serve as their own controls for the analyses of healthcare utilization. If a potential patient needs to switch from their current antipsychotic medication they are eligible for this study. The investigator will determine that the patient may benefit equally from switching to either paliperidone ER (extended release) or to either of 2 other antipsychotics. Healthcare use over the 12-month period prior to baseline (the "pre-period") will be compared to the 12-month period following the start of paliperidone ER or other AAP (the "post-period"). Data for both periods will be obtained by study investigators from enrolled patients' medical charts. Patients will continue to be followed in the study, regardless of change in treatment, until visit 5 at month 12 or if withdrawn from the study. All patients will receive medical care consistent with local medical practices.

  Eligibility

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

The majority of patients with schizophrenia are treated in the outpatient setting. Therefore, this study will focus largely on the population treated in Community Mental Health Centers (CMHCs), Veteran Affairs (VAs) Centers, as well as private practice and other treatment settings.

Criteria

Inclusion Criteria:

  • Must have a clinical diagnosis of schizophrenia for at least 1 year prior to screening
  • Had been receiving treatment with antipsychotics, but is judged to be a candidate for changing antipsychotic on the basis of either persistent symptoms or continuing side effects
  • Treating physician has determined, before the patient enters the study, that starting paliperidone extended release (ER) or another of at least two possible atypical antipsychotics (AAPs) is an appropriate treatment for the patient
  • Likely to be managed as outpatient
  • Must have signed the informed consent form for DNA pharmacogenomic

Exclusion Criteria:

  • Have mental retardation, dementia, bipolar, schizoaffective disorder, schizophreniform disease, other Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) psychiatric disorders or deteriorating neurological illnesses as determined by clinical evaluation
  • Established treatment-resistant schizophrenia, defined as those who have had treatment failures with adequate trials of two second generation atypicals, previous treatment with clozapine, or 4 or more hospitalizations in the last 12 months
  • History of recent violence or at immediate risk of suicide, or harming self or others, or of causing damage to property, in the judgment of the investigator
  • Patients who are unable to swallow the medication whole
  • History or circumstances that may increase the risk of occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including bradycardia, hypokalemia or hypomagnesemia, concomitant use of drugs that prolong the QTc interval, or presence of congenital long QT syndrome
  • Pregnant (as confirmed by urine pregnancy test performed at baseline), planning to become pregnant, or breast-feeding.
  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: NCT00488891

Sponsors and Collaborators
Ortho-McNeil Janssen Scientific Affairs, LLC
Investigators
Study Director: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial Ortho-McNeil Janssen Scientific Affairs, LLC
  More Information

No publications provided

Responsible Party: Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00488891     History of Changes
Other Study ID Numbers: CR014143, PAL-OUT-003
Study First Received: June 18, 2007
Last Updated: August 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ortho-McNeil Janssen Scientific Affairs, LLC:
Schizophrenia
Paliperdone ER
Invega
Observational
Antipsychotic agents

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

ClinicalTrials.gov processed this record on July 28, 2014