Clinical trial NCT00535132: Study to Measure Drug Satisfaction of Patients With Schizophrenia After Switching From Risperidone to Paliperidone
Official title: A Blinded-initiation Study of Medication Satisfaction in Subjects With Schizophrenia Treated With Paliperidone ER After Suboptimal Response to Oral Risperidone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: schizophrenia
medication satisfaction, Invega
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint.
timeFrame: Change from Baseline in MSQ Score at Week 6 Last Observation Carried Forward (LOCF)
Secondary outcomes:
measure: Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed).
timeFrame: Change from Baseline in MSQ Score at Week 2
measure: Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed).
timeFrame: Change from Baseline in MSQ Score at Week 4
measure: Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed).
timeFrame: Change from Baseline in MSQ Score at Week 6
measure: Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed).
timeFrame: Week 2
measure: Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed).
timeFrame: Week 4
measure: Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed).
timeFrame: Week 6
measure: Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF.
timeFrame: Week 6 LOCF
measure: Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint
timeFrame: Change from Baseline to Week 6 LOCF
measure: Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint
timeFrame: Change from Baseline to Week 6 LOCF
measure: Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint
timeFrame: Change from Baseline to Week 6 LOCF
measure: Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint
timeFrame: Change from Baseline to Week 6 LOCF
measure: Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint
timeFrame: Change from Baseline to Week 6 LOCF
Other outcomes:
measure: Positive and Negative Syndrome Scale (PANSS) Total Score Change From Baseline to Week 6 Endpoint
timeFrame: Change from Baseline to Week 6 LOCF
measure: Clinical Global Impression - Severity (CGI-S) Change From Baseline to Week 6 Endpoint
timeFrame: Change from Baseline to Week 6 LOCF
Locations:
city: Cerritos
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Pico Rivera
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Torrance
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Flowood
country: United States
state: Mississippi
city: Clementon
country: United States
state: New Jersey
city: Brooklyn
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Miami
country: Argentina
state: FL
city: Buenos Aires
country: Argentina
city: Ciudad Autonoma De
country: Argentina
city: Cordoba Crd
country: Argentina
city: Mendoza Men
country: Argentina
city: Mendoza
country: Argentina
city: Rosario
country: Argentina
city: Barranquilla N/A
country: Colombia
city: Bogota
country: Colombia
city: Bogotá S/N
country: Colombia
city: Bucaramanga S/N
country: Colombia
city: Plzen
country: Czech Republic
city: Praha 10
country: Czech Republic
city: Praha 5
country: Czech Republic
city: Praha 6
country: Czech Republic
city: Sternberk 1
country: Czech Republic
city: Bojnice
country: Slovakia
city: Bratislava
country: Slovakia
city: Michalovce
country: Slovakia
city: Rimavska Sobota
country: Slovakia
city: Zilina
country: Slovakia
city: Dnipropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
city: Village Stepanovka Kherson
country: Ukraine
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.