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

NCT ID: NCT00535132

Last Updated: 2014-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-07-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

002

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

Group Type: EXPERIMENTAL

Oral Risperidone

Intervention Type: DRUG

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

001

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

Group Type: EXPERIMENTAL

Paliperidone ER

Intervention Type: DRUG

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

Interventions

Oral Risperidone

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

Intervention Type: DRUG

Paliperidone ER

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

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

Atlanta, Georgia, United States

Chicago, Illinois, United States

Flowood, Mississippi, United States

Clementon, New Jersey, United States

Brooklyn, New York, United States

Philadelphia, Pennsylvania, United States

Austin, Texas, United States

Irving, Texas, United States

Miami, FL, Argentina

Buenos Aires, , Argentina

Ciudad Autonoma de, , Argentina

Cordoba Crd, , Argentina

Mendoza, , Argentina

Mendoza Men, , Argentina

Rosario, , Argentina

Barranquilla, , Colombia

Bogotá, , Colombia

Bogotá S/N, , Colombia

Bucaramanga S/N, , Colombia

Pilsen, , Czechia

Prague, , Czechia

Sternberk, , Czechia

Bojnice, , Slovakia

Bratislava, , Slovakia

Michalovce, , Slovakia

Rimavská Sobota, , Slovakia

Žilina, , Slovakia

Dnipropetrovsk, , Ukraine

Donetsk, , Ukraine

Kiev, , Ukraine

Lviv, , Ukraine

Odesa, , Ukraine

Village Stepanovka Kherson, , Ukraine

Countries

United States; Argentina; Colombia; Czechia; Slovakia; Ukraine

References

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.

Reference Type: DERIVED

PMID: 20216424 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=76&filename=CR014347_CSR.pdf

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

Other Identifiers

R076477SCH4013

Identifier Type: -

Identifier Source: secondary_id

CR014347

Identifier Type: -

Identifier Source: org_study_id