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

Schizophrenia Clinical Trial

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Official title:

The Paliperidone ER Outcomes Study of Schizophrenia Patients in Typical Clinical Practice

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00488891
• Other study ID #: CR014143
• Secondary ID: PAL-OUT-003
• Status: Terminated
• Phase: Phase 4
• First received: June 18, 2007
• Last updated: August 28, 2012
• Start date: April 2007
• Est. completion date: October 2007

Study information

• Verified date: August 2012
• Source: Ortho-McNeil Janssen Scientific Affairs, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ortho-McNeil Janssen Scientific Affairs, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the yearly rate of hospital admissions before and after treatment with paliperidone extended release (ER)	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]).	12 months before and post baseline	No
Secondary	Change from baseline in Clinical Global Impression of the severity (CGI-S) scale	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).	Baseline to Month 12	No
Secondary	Change from baseline in Positive and Negative Syndrome Scale (PANSS)	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).	Baseline to Month 12	No
Secondary	Change from baseline in Personal and Social Performance Scale (PSP and SF-36)	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).	Baseline to Month 12	No
Secondary	Change from baseline in Independent Living Skills Survey (ILSS)	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.	Baseline to Month 12	No
Secondary	Change from baseline in Healthcare and Social Services Resource Utilization	Resource utilization includes healthcare and social services such as inpatient and outpatient hospital use, emergency room visits, and crisis team interventions.	Baseline to Month 12	No
Secondary	Relapse rate	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).	Baseline to Month 12	Yes
Secondary	Change from baseline in Abnormal Involuntary Movement Scale (AIMS)	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."	Baseline and Month 12	Yes
Secondary	Change from baseline in Clinical Global Impression of change scale (CGI-C)	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).	Month 3 to Month 12	No
Secondary	Change from baseline in Short-Form 36 Health Survey (SF-36)	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.	Baseline to Month 12	No
Secondary	Change from baseline in Medication Compliance with Antipsychotic Medication	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.	Baseline to Month 12	No
Secondary	Change from baseline in Patient Satisfaction with Antipsychotic Medication	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.	Baseline to Month 12	No
Secondary	Changes in safety parameters	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	Baseline to Month 12	Yes