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SchizophreniaPhase 4NCT00535132

Study to Measure Drug Satisfaction of Patients With Schizophrenia After Switching From Risperidone to Paliperidone

A Phase 4 study testing Oral Risperidone and Paliperidone ER in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 40 sites in 6 countries.

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 medication satisfaction after at least 4 weeks of paliperidone ER (extended-release), an antipsychotic, treatment in patients with schizophrenia who were previously taking either 4 or 6 mg of risperidone daily by mouth, but who are not satisfied with their treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia
What is being tested?
Oral Risperidone and Paliperidone ER
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
40 sitesin 6 countries
Study dates
Oct 2007to Jul 2008
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

  • Must be able to understand, in the opinion of the investigator, the informed consent form.
  • be diagnosed with schizophrenia
  • report dissatisfaction with current medication
  • have an aspect of schizophrenia management which could potentially benefit from a change in antipsychotic medication
  • receive risperidone 4 mg or 6 mg for at least 4 weeks before the start of the study.

Who cannot join

  • Unable to swallow study drug whole with the aid of water
  • cannot have received an investigational drug, used an investigational medical device, or participated in a clinical study that altered their medication within 6 months before the first administration of study drug, or have participated in more than 2 investigational drug studies within the past 12 months
  • no other major mental health diagnosis except for tobacco dependance
  • no use of cocaine or heroin within 3 months before the first administration
  • no history of treatment with any antipsychotic in addition to treatment with risperidone, or treatment with paliperidone, within 30 days before the baseline visit.

Trial locations and contacts

40 sites in 6 countries.

40 sites in 6 countries

United States15 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Brooklyn, New York

  • Study site

    Cerritos, California

  • Study site

    Chicago, Illinois

  • Study site

    Clementon, New Jersey

  • Study site

    Flowood, Mississippi

  • Study site

    Garden Grove, California

  • Study site

    Huntington Beach, California

  • Study site

    Irving, Texas

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Pico Rivera, California

  • Study site

    San Diego, California

  • Study site

    Santa Ana, California

  • Study site

    Torrance, California

Other trials in United States

Argentina7 sites

  • Study site

    Buenos Aires

  • Study site

    Ciudad Autonoma de

  • Study site

    Cordoba Crd

  • Study site

    Mendoza

  • Study site

    Mendoza Men

  • Study site

    Miami, FL

  • Study site

    Rosario

Other trials in Argentina

Ukraine6 sites

  • Study site

    Dnipropetrovsk

  • Study site

    Donetsk

  • Study site

    Kiev

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Village Stepanovka Kherson

Other trials in Ukraine

Slovakia5 sites

  • Study site

    Bojnice

  • Study site

    Bratislava

  • Study site

    Michalovce

  • Study site

    Rimavská Sobota

  • Study site

    Žilina

Other trials in Slovakia

Colombia4 sites

  • Study site

    Barranquilla

  • Study site

    Bogotá

  • Study site

    Bogotá S/N

  • Study site

    Bucaramanga S/N

Other trials in Colombia

Czechia3 sites

  • Study site

    Pilsen

  • Study site

    Prague

  • Study site

    Sternberk

Other trials in Czechia

About this study

Official title: A Blinded-initiation Study of Medication Satisfaction in Subjects With Schizophrenia Treated With Paliperidone ER After Suboptimal Response to Oral Risperidone

The purpose of this study is to evaluate medication satisfaction after at least 4 weeks of paliperidone ER (extended-release), an antipsychotic, treatment in patients with schizophrenia who were previously taking either 4 or 6 mg of risperidone daily by mouth, but who are not satisfied with their treatment.

Read the detailed description

Paliperidone ER has been shown to be effective compared to placebo ("a sugar pill") in the acute treatment and maintenance of patients with schizophrenia. Paliperidone ER combines an active metabolite of another antipsychotic, risperidone, with manufacturing technology allowing more gradual release of the drug and less difference in high and low blood levels of the drug. Side effects to medications are sometimes due to wide differences in these high and low blood levels. Recent research has shown that many patients with schizophrenia discontinue their antipsychotic medication due to "subject-choice". Therefore, it is important that research studies attempt to measure patients' satisfaction with antipsychotic medication, in addition to measuring how they respond on tests of effectiveness. This study has been designed to evaluate antipsychotic medication satisfaction in patients who continue to have symptoms of schizophrenia, and who say they are dissatisfied with their current risperidone treatment. The primary outcome is the change in the Medication Satisfaction Questionnaire (MSQ) score, from baseline to the Week 6 endpoint. These patients are randomized (like flipping a coin) as to when their risperidone (4 mg to 6 mg per day) is switched to paliperidone ER. Because the study is 'blinded', neither the study doctor nor the patient will know when treatment with risperidone is stopped and treatment with paliperidone ER begins. Throughout the study all patients continue to receive antipsychotic medication daily. Patients will continue on the same daily dose of risperidone until their randomly assigned switch to paliperidone ER. All patients will be switched to paliperidone ER over the course of study and once switched continue to take paliperidone ER for the remainder of the study. Paliperidone ER is started at 6 mg/day and can be increased to 9 mg/day or 12 mg/day at the doctor's discretion. Effectiveness and safety will be measured at visits scheduled weekly for the first four weeks and then at the Week 6 endpoint. At each visit, patients will be asked to complete psychiatric tests and questionnaires that will measure effectiveness and patient satisfaction with the medicine. They will also complete tests and evaluations for safety, including electrocardiograms (ECGs, electrical tracings of the heart) and blood samples at the beginning and end of the study. Each patient receives two blinded capsules by mouth once daily in the morning for 6 weeks. Patients taking risperidone receive either a 4-mg or 6-mg capsule plus a placebo capsule. When patients are switched, Paliperidone ER is started at 6 mg/day the day after risperidone is discontinued and can be increased to 9 mg/day or 12 mg/day at the doctor's discretion. Paliperidone 3-mg and 6-mg capsules are combined with placebo to equal the total dose in two capsules.

Conditions
Schizophrenia
Being tested
Oral Risperidone, Paliperidone ER
Keywords
schizophrenia, medication satisfaction, Invega
Medical subject headings
Schizophrenia

What participants receive

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

  • Oral RisperidoneDrug

    4 or 6 mg MG once daily for 0-2 weeks

  • Paliperidone ERDrug

    6, 9 or 12 MG once daily for 4-6 weeks

Study groups in NCT00535132
Study groupRoleWhat they receive
002ExperimentalOral Risperidone 4 or 6 mg MG once daily for 0-2 weeks
Receives: Drug: Oral Risperidone
001ExperimentalPaliperidone ER 6, 9 or 12 MG once daily for 4-6 weeks
Receives: Drug: Paliperidone ER

What is being measured

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

  1. Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint.

    The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).

    Measured: Change from Baseline in MSQ Score at Week 6 Last Observation Carried Forward (LOCF)

Secondary outcomes (12)

  1. Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed).

    The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).

    Measured: Change from Baseline in MSQ Score at Week 2

  2. Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed).

    The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).

    Measured: Change from Baseline in MSQ Score at Week 4

  3. Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed).

    The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).

    Measured: Change from Baseline in MSQ Score at Week 6

  4. Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed).

    The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).

    Measured: Week 2

  5. Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed).

    The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).

    Measured: Week 4

  6. Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed).

    The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).

    Measured: Week 6

  7. Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF.

    The MSQ is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied).

    Measured: Week 6 LOCF

  8. Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint

    The TSQM is a 14-item subject-assessed evaluation of treatment medication including 4 factors, Effectiveness (items 1-3), Side Effects (items 4-8), Convenience (items 9-11)and Global Satisfaction (items 12-14). Item 14 states "taking all things into account, how satisfied or dissatisfied are you with this medication?" and utilizes the following responses on a 7-point Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100.

    Measured: Change from Baseline to Week 6 LOCF

  9. Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint

    The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. 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. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.

    Measured: Change from Baseline to Week 6 LOCF

  10. Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint

    The SF-36 is a well-validated and widely used quality-of-life instrument employed in numerous disease states, including schizophrenia. 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. Scoring of the SF-36 was based on the SF-36 Manual and Interpretation Guide. Worst value is 0 and best value is 100.

    Measured: Change from Baseline to Week 6 LOCF

  11. Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint

    The PSQI is a 2-part questionnaire that assesses sleep quality and disturbances in seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each domain is rated on a 4-point scale as follows: 0=Not during the past month, 1=Less than once a week, 2=Once or twice a week, 3=Three or more times a week. Total scores range from zero to 21; increasing scores indicate poorer sleep quality and total scores greater than 5 suggest significant sleep disturbance.

    Measured: Change from Baseline to Week 6 LOCF

  12. Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint

    The standard COVI Anxiety Scale is an investigator-assessed measure of the severity of anxiety symptoms on 4 items: verbal report, behavior, somatic symptoms, and relationship to study drug. Each dimension is assessed in 5 to 10 minutes using a 5-point scale as follows: 1=Not at all, 2=Somewhat, 3=Moderately, 4=Considerably, to 5=Very much. For this study, the standard COVI Anxiety Scale was modified to improve psychometric properties by incorporating anchor points for symptom severity, frequency, and duration and for functional impairment. Worst value is 20 and best value is 4.

    Measured: Change from Baseline to Week 6 LOCF

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 completionJul 2008
  4. Study completionJul 2008

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00535132
Sponsor's protocol ID
CR014347
Other IDs
R076477SCH4013
Status last verified
Apr 2014
First submitted
24 Sep 2007
Last updated
9 May 2014

Publications

  • Canuso CM, Grinspan A, Kalali A, Damaraju CV, Merriman U, Alphs L, Awad AG. Medication satisfaction in schizophrenia: a blinded-initiation study of paliperidone extended release in patients suboptimally responsive to risperidone. Int Clin Psychopharmacol. 2010 May;25(3):155-64. doi: 10.1097/YIC.0b013e3283372977.

    PubMed 20216424

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oral Risperidone and Paliperidone ER in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 40 sites in 6 countries.

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 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 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Argentina, Ukraine, Slovakia, Colombia and 1 more country. 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 Oct 2009). 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?

Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint. (time frame: Change from Baseline in MSQ Score at Week 6 Last Observation Carried Forward (LOCF)). 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 NCT00535132, which also lists 1 linked publication.

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 9 May 2014.

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