Clinical trial NCT00488891: The Paliperidone ER Observational Study of Economic, Functional, and Clinical Outcomes in Patients With Schizophrenia
Official title: The Paliperidone ER Outcomes Study of Schizophrenia Patients in Typical Clinical Practice
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperdone ER
Invega
Observational
Antipsychotic agents
Lead sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2007-06-20
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: Changes in the yearly rate of hospital admissions before and after treatment with paliperidone extended release (ER)
timeFrame: 12 months before and post baseline
Secondary outcomes:
measure: Change from baseline in Clinical Global Impression of the severity (CGI-S) scale
timeFrame: Baseline to Month 12
measure: Change from baseline in Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline to Month 12
measure: Change from baseline in Personal and Social Performance Scale (PSP and SF-36)
timeFrame: Baseline to Month 12
measure: Change from baseline in Independent Living Skills Survey (ILSS)
timeFrame: Baseline to Month 12
measure: Change from baseline in Healthcare and Social Services Resource Utilization
timeFrame: Baseline to Month 12
measure: Relapse rate
timeFrame: Baseline to Month 12
measure: Change from baseline in Abnormal Involuntary Movement Scale (AIMS)
timeFrame: Baseline and Month 12
measure: Change from baseline in Clinical Global Impression of change scale (CGI-C)
timeFrame: Month 3 to Month 12
measure: Change from baseline in Short-Form 36 Health Survey (SF-36)
timeFrame: Baseline to Month 12
measure: Change from baseline in Medication Compliance with Antipsychotic Medication
timeFrame: Baseline to Month 12
measure: Change from baseline in Patient Satisfaction with Antipsychotic Medication
timeFrame: Baseline to Month 12
measure: Changes in safety parameters
timeFrame: Baseline to Month 12
Other outcomes:
Locations:
Study officials:
affiliation: Ortho-McNeil Janssen Scientific Affairs, LLC
name: Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References: