A Blinded-initiation Study of Medication Satisfaction in Subjects With Schizophrenia Treated With Paliperidone ER After Suboptimal Response to Oral Risperidone
Overview
- Phase
- Phase 4
- Intervention
- Oral Risperidone
- Conditions
- Schizophrenia
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Enrollment
- 201
- Primary Endpoint
- Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint.
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
002
Oral Risperidone 4 or 6 mg MG once daily for 0-2 weeks
Intervention: Oral Risperidone
001
Paliperidone ER 6, 9 or 12 MG once daily for 4-6 weeks
Intervention: Paliperidone ER
Outcomes
Primary Outcomes
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)
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).
Secondary Outcomes
- Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed).(Change from Baseline in MSQ Score at Week 2)
- Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed).(Change from Baseline in MSQ Score at Week 4)
- Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed).(Change from Baseline in MSQ Score at Week 6)
- Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed).(Week 2)
- Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed).(Week 4)
- Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed).(Week 6)
- Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF.(Week 6 LOCF)
- Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint(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(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(Change from Baseline to Week 6 LOCF)
- Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint(Change from Baseline to Week 6 LOCF)
- Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint(Change from Baseline to Week 6 LOCF)