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SchizophreniaPhase 4NCT00535145

Study to Measure the Safety of Paliperidone ER (Extended-release) in Patients With Liver Disease

A Phase 4 study testing Treatment as usual (TAU), Paliperidone ER in people with Schizophrenia and Schizoaffective Disorder, run by Ortho-McNeil Janssen Scientific Affairs, LLC at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the tolerability and safety of paliperidone ER (extended-release) in doses between 3 milligrams per day and 12 milligrams per day in the treatment of patients with schizophrenia or schizoaffective disorder and liver disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Treatment as usual (TAU), Paliperidone ER
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
21 sitesUnited States
Study dates
Oct 2007to Feb 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study, and must also have a negative urine pregnancy test at Screening
  • Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder
  • Must have identified current, stable liver disease (e.g., viral hepatitis, alcoholic cirrhosis)
  • Child-Pugh class A or B (total score < 10)

Who cannot join

  • Not able to swallow the study medication whole with the aid of water
  • Not currently meeting criteria for any other Axis I diagnosis, including a DSM-IV diagnosis of Bipolar Disorder
  • Not using alcohol in the previous 2 weeks or meeting the DSM-IV criteria for substance abuse or dependence or alcohol abuse or dependence in the 6 months before study entry
  • Not experiencing severe liver disease or an acute exacerbation of the underlying liver disease (Child-Pugh total score >=10)
  • No evidence of severe hepatic decompensation within the previous 3 months, such as: ascites not controlled with diuretics, peritonitis, portal hypertension or gross hepatic encephalopathy (eg, somnolence, stupor, coma)

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Cerritos, California

  • Study site

    Chino, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Clementon, New Jersey

  • Study site

    Flowood, Mississippi

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Garden Grove, California

  • Study site

    Hollywood, Florida

  • Study site

    Huntington Beach, California

  • Study site

    Irving, Texas

  • Study site

    Kansas City, Missouri

  • Study site

    Kissimmee, Florida

  • Study site

    Lake Charles, Louisiana

  • Study site

    Norristown, Pennsylvania

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Santa Ana, California

  • Study site

    Sioux Falls, South Dakota

  • Study site

    Staten Island, New York

  • Study site

    Torrance, California

  • Study site

    White River Junction, Vermont

Other trials in United States

About this study

Official title: A Single-arm Evaluation of the Safety of Paliperidone Extended-Release (ER) in Subjects With Schizophrenia or Schizoaffective Disorder With Hepatic Disease

The purpose of this study is to evaluate the tolerability and safety of paliperidone ER (extended-release) in doses between 3 milligrams per day and 12 milligrams per day in the treatment of patients with schizophrenia or schizoaffective disorder and liver disease.

Read the detailed description

Patients with schizophrenia or schizoaffective disorder commonly have other conditions that may affect the liver, such as alcohol abuse and/or chronic liver infections (hepatitis). Although single-dose studies in patients with liver disease are conducted to test the safety of medications, there is less information about the safety of treatment with medications for schizophrenia in this at-risk population of patients with schizophrenia or schizoaffective disorder and liver disease. This 9-week study is open-label (both patient and investigators know what study drug and dose of study drug the patient is taking) and has 2 phases. During Phase 1, which lasts 4 weeks, patients will continue to take whatever medication they are already taking for schizophrenia (TAU, or treatment as usual). During the first week of Phase 2, patients will receive decreasing doses of TAU and increasing doses of paliperidone ER. For the rest of Phase 2, which lasts 4 more weeks, patients will take paliperidone ER in doses between 3 mg/day and 12 mg/day, as prescribed by the study doctor. This study will evaluate adverse events and will use several scales and tests to measure the effectiveness of paliperidone ER in patients with an established diagnosis of schizophrenia or schizoaffective disorder and liver disease. Study assessments include the PANSS (Positive and Negative Symptom Scale for Schizophrenia), CGI (Clinical Global Impression scale), MSQ (Medication Satisfaction Questionnaire), sleep VAS (Visual Analog Scale), SF-36 (Short Form 36 Health Survey), and PSP (Personal and Social Performance Scale). Each assessment will be performed at least two times during the course of the study, but some assessments will be done more frequently. Visits are scheduled every 1 to two weeks during the 9 week study.

The hypothesis is that paliperidone ER can be used safely in patients with schizophrenia or schizoaffective disorder who also have identified liver disease. During Phase 1 of the study, patients will continue to take whatever medication they are already taking for schizophrenia (TAU, or treatment as usual) for 4 weeks. For the first week of Phase 2, patients will receive decreasing doses of TAU. During Phase 2, patients will take paliperidone ER in doses between 3 milligrams per day and 12 milligrams per day by mouth for 5 weeks.

Being tested
Treatment as usual (TAU), Paliperidone ER
Keywords
antipsychotic, paliperidone ER, liver disease, Schizophrenia, Schizoaffective Disorder, Invega
Medical subject headings
Schizophrenia, Psychotic Disorders, Liver Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment as usual (TAU), Paliperidone ERDrug

    Treatment as usual is the subject's current antipsychotic and doses for 4 weeks; TAU AND Paliperidone ER - per site investigator for 1 week; Paliperidone ER 6mg once daily for 1 week; Paliperidone ER-3 to 12mg tablets once daily for 4 weeks

Study groups in NCT00535145
Study groupRoleWhat they receive
001ExperimentalTreatment as usual (TAU), Paliperidone ERTreatment as usual is the subject's current antipsychotic and doses for 4 weeks; TAU AND Paliperidone ER - per site investigator for 1 week; Paliperidone ER 6mg once daily for 1 week; Paliperidone ER-3 to 12mg tablets once daily for 4 weeks
Receives: Drug: Treatment as usual (TAU), Paliperidone ER

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Difference in the Incidence of Any Adverse Events When Patients Switch Their Antipsychotic From Treatment as Usual (TAU) to Paliperidone ER

    Adverse Event summary for both serious adverse events and other adverse events. Please see the Clinical Study Report Synopsis for results on this primary outcome measure or the AE section for a detailed breakdown of each adverse event preferred term in both categories.

    Measured: Day 1 - Day 62

Secondary outcomes (3)

  1. Positive and Negative Symptoms of Schizophrenia (PANSS) Change From Baseline

    The PANSS is a 30-item scale (range 30-210) 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 (1="Absent", 2="Minimal", 3="Mild", 4="Moderate", 5="Moderate/Severe", 6="Severe", 7="Extreme").The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.

    Measured: Day 1 - Day 62

  2. Clinical Global Impression of Severity (CGI-S) Change From Baseline

    The CGI-S (range 1-7) is a standardized, clinician-rated assessment to rate the severity of illness of the patient. The clinician assessed the severity of illness using the following categories: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill. The minimum score is 1 and maximum score is 7, with higher scores indicating more severe illness.

    Measured: Day 1 - Day 62

  3. Personal and Social Performance Score (PSP) Change From Baseline

    The PSP (range 1-100) is a validated clinician-rated assessment of functioning. Four areas of functioning (socially useful activities, personal/social relationships, self-care, disturbing/aggressive behaviors) are assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.

    Measured: Day 1 - Day 62

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00535145
Sponsor's protocol ID
CR014341
Other IDs
R076477SCH4005
Status last verified
Jul 2014
First submitted
24 Sep 2007
Last updated
25 Jul 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Treatment as usual (TAU), Paliperidone ER in people with Schizophrenia and Schizoaffective Disorder, run by Ortho-McNeil Janssen Scientific Affairs, LLC at 21 sites in United States.

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 4 inclusion and 5 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: finished, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Difference in the Incidence of Any Adverse Events When Patients Switch Their Antipsychotic From Treatment as Usual (TAU) to Paliperidone ER (time frame: Day 1 - Day 62). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00535145.

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 25 Jul 2014.

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