SchizophreniaPOSTNCT00488891
The Paliperidone ER Observational Study of Economic, Functional, and Clinical Outcomes in Patients With Schizophrenia
An observational study of Schizophrenia, run by Ortho-McNeil Janssen Scientific Affairs, LLC.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paliperidone ER and Atypical antipsychotics (AAP)
- Type of treatment
- Pill or oral medicine
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Oct 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: The Paliperidone ER Outcomes Study of Schizophrenia Patients in Typical Clinical Practice
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone ER, Atypical antipsychotics (AAP)
- Keywords
- Schizophrenia, Paliperdone ER, Invega, Observational, Antipsychotic agents
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone ERDrug
Also called Invega
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)Drug
Route = oral. AAP including quetiapine, risperidone, olanzapine, ziprasidone or aripiprazole. Dosage and administration of antipsychotics will be prescribed at the investigator's discretion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Atypical antipsychotics (AAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]).
Measured: 12 months before and post baseline
Secondary outcomes (12)
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).
Measured: Baseline to Month 12
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).
Measured: Baseline to Month 12
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).
Measured: Baseline to Month 12
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.
Measured: Baseline to Month 12
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.
Measured: Baseline to Month 12
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).
Measured: Baseline to Month 12
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."
Measured: Baseline and Month 12
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).
Measured: Month 3 to Month 12
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.
Measured: Baseline to Month 12
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.
Measured: Baseline to Month 12
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.
Measured: Baseline to Month 12
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
Measured: Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startApr 2007
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: The study was terminated because it was not enrolling at the expected rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study director, Ortho-McNeil Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488891
- Sponsor's protocol ID
- CR014143
- Other IDs
- PAL-OUT-003
- Acronym
- POST
- Status last verified
- Aug 2012
- First submitted
- 18 Jun 2007
- Last updated
- 29 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Paliperidone ER Outcomes Study of Schizophrenia Patients in Typical Clinical Practice
- ClinicalTrials.gov ID
- NCT00488891
- Acronym / sponsor ID
- POST / CR014143
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Paliperdone ER, Invega, Observational, Antipsychotic agents
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated because it was not enrolling at the expected rate
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 20 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paliperidone extended release (ER) | – | Drug: Paliperidone ERDrug: 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 agent (AAP) | – | Drug: Atypical antipsychotics (AAP)AAP includes quetiapine, risperidone, olanzapine, ziprasidone or aripiprazole. Dosage and administration of antipsychotics will be prescribed at the investigator's discretion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paliperidone ERAlso: InvegaRoute = 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 | Drug | Paliperidone extended release (ER) |
| 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 | Drug | Atypical antipsychotics agent (AAP) |
Primary outcome
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]).
12 secondary outcomes
Change from baseline in Clinical Global Impression of the severity (CGI-S) scale
Time frame: Baseline to Month 12
Change from baseline in Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline to Month 12
Change from baseline in Personal and Social Performance Scale (PSP and SF-36)
Time frame: Baseline to Month 12
Change from baseline in Independent Living Skills Survey (ILSS)
Time frame: Baseline to Month 12
Change from baseline in Healthcare and Social Services Resource Utilization
Time frame: Baseline to Month 12
Relapse rate
Time frame: Baseline to Month 12
Change from baseline in Abnormal Involuntary Movement Scale (AIMS)
Time frame: Baseline and Month 12
Change from baseline in Clinical Global Impression of change scale (CGI-C)
Time frame: Month 3 to Month 12
Change from baseline in Short-Form 36 Health Survey (SF-36)
Time frame: Baseline to Month 12
Change from baseline in Medication Compliance with Antipsychotic Medication
Time frame: Baseline to Month 12
Change from baseline in Patient Satisfaction with Antipsychotic Medication
Time frame: Baseline to Month 12
Changes in safety parameters
Time frame: Baseline to Month 12
Results and safety
The study was stopped early (reason given: The study was terminated because it was not enrolling at the expected rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial study director
Ortho-McNeil Janssen Scientific Affairs, LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Ortho-McNeil Janssen Scientific Affairs, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated because it was not enrolling at the expected rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2012.