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

NCT00488891 | Terminated

• 2 other identifiers: CR014143PAL-OUT-003
• Study Type: observational
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperdone ER; Invega; Observational; Antipsychotic agents

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Change from baseline in Clinical Global Impression of the severity (CGI-S) scale

  Baseline to Month 12

• Change from baseline in Positive and Negative Syndrome Scale (PANSS)

  Baseline to Month 12

• Change from baseline in Personal and Social Performance Scale (PSP and SF-36)

  Baseline to Month 12

• Change from baseline in Independent Living Skills Survey (ILSS)

  Baseline to Month 12

• Change from baseline in Healthcare and Social Services Resource Utilization

  Baseline to Month 12

Study Arms (2)

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

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)

Interventions

Paliperidone ER DRUG

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

Also known as: Invega

Paliperidone extended release (ER)

Atypical antipsychotics (AAP) DRUG

Route = oral. AAP including quetiapine, risperidone, olanzapine, ziprasidone or aripiprazole. Dosage and administration of antipsychotics will be prescribed at the investigator's discretion

Atypical antipsychotics agent (AAP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ortho-McNeil Janssen Scientific Affairs, LLC: lead

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial

  Ortho-McNeil Janssen Scientific Affairs, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2007
• First Posted: June 20, 2007
• Study Start: April 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: August 29, 2012

Record last verified: 2012-08