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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Oral Risperidone; Drug: Paliperidone ER

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.

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
  • Ciudad Autonoma De, Argentina
  • Cordoba Crd, Argentina
  • Mendoza, Argentina
  • Mendoza Men, Argentina
  • Rosario, Argentina
  • FL
    • Miami, FL, Argentina
• Colombia
  • Barranquilla N/A, Colombia
  • Bogota, Colombia
  • Bogotá S/N, Colombia
  • Bucaramanga S/N, Colombia
• Czech Republic
  • Plzen, Czech Republic
  • Praha 10, Czech Republic
  • Praha 5, Czech Republic
  • Praha 6, Czech Republic
  • Sternberk 1, Czech Republic
• Slovakia
  • Bojnice, Slovakia
  • Bratislava, Slovakia
  • Michalovce, Slovakia
  • Rimavska Sobota, Slovakia
  • Zilina, Slovakia
• Ukraine
  • Dnipropetrovsk, Ukraine
  • Donetsk, Ukraine
  • Kiev, Ukraine
  • Lviv, Ukraine
  • Odessa, Ukraine
  • Village Stepanovka Kherson, Ukraine
• United States
  • California
    • Cerritos, California, United States
    • Garden Grove, California, United States
    • Huntington Beach, California, United States
    • Pico Rivera, California, United States
    • San Diego, California, United States
    • Santa Ana, California, United States
    • Torrance, California, United States
  • Georgia
    • Atlanta, Georgia, United States
  • Illinois
    • Chicago, Illinois, United States
  • Mississippi
    • Flowood, Mississippi, United States
  • New Jersey
    • Clementon, New Jersey, United States
  • New York
    • Brooklyn, New York, United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
  • Texas
    • Austin, Texas, United States
    • Irving, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 002; Oral Risperidone 4 or 6 mg MG once daily for 0-2 weeks	Drug: Oral Risperidone; 4 or 6 mg MG once daily for 0-2 weeks
Experimental: 001; Paliperidone ER 6, 9 or 12 MG once daily for 4-6 weeks	Drug: Paliperidone ER; 6, 9 or 12 MG once daily for 4-6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Change from Baseline in MSQ Score at Week 6 Last Observation Carried Forward (LOCF)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Change from Baseline in MSQ Score at Week 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).	Change from Baseline in MSQ Score at Week 4
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).	Change from Baseline in MSQ Score at Week 6
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).	Week 2
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).	Week 4
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).	Week 6
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).	Week 6 LOCF
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.	Change from Baseline to Week 6 LOCF
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.	Change from Baseline to Week 6 LOCF
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.	Change from Baseline to Week 6 LOCF
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.	Change from Baseline to Week 6 LOCF
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.	Change from Baseline to Week 6 LOCF

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint	The PANSS is a 30-item scale designed to capture numerous symptoms of schizophrenia, including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale as follows: 1=Absent, 2=Minimal, 3=Mild,4=Moderate, 5=Moderate Severe, 6=Severe, 7=Extreme. This scale has been shown to be sensitive to changes associated with medication treatment. In addition to a total score, this assessment yields separate scores along a Positive Syndrome, a Negative Syndrome, and a General Psychopathology Scales. Worst value is 210, best value is 30.	Change from Baseline to Week 6 LOCF
Clinical Global Impression - Severity (CGI-S) Change From Baseline to Week 6 Endpoint	The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a subject. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill subjects". Worst value is 7 and best value is 1.	Change from Baseline to Week 6 LOCF

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

General 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.

Helpful Links

• A blinded-initiation study of medication satisfaction in subjects with schizophrenia treated with paliperidone ER after suboptimal response to oral risperidone

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: September 24, 2007
• First Submitted That Met QC Criteria: September 24, 2007
• First Posted (Estimate): September 26, 2007

Study Record Updates

• Last Update Posted (Estimate): May 9, 2014
• Last Update Submitted That Met QC Criteria: April 24, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: schizophrenia; medication satisfaction, Invega
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Paliperidone Palmitate; Risperidone
• Other Study ID Numbers: CR014347; R076477SCH4013