Phase 4
N=201
Study to Measure Drug Satisfaction of Patients With Schizophrenia After Switching From Risperidone to Paliperidone
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00535132 ↗Enrolled (actual)
201
Serious AEs
3.6%
Results posted
Oct 2009
Primary outcome: Primary: Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint. — 2.5; 2.3; 2.4 Points on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oral Risperidone (Drug); Paliperidone ER (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to the Week 6 Endpoint. |
2.5; 2.3; 2.4 | <0.001 sig |
| SECONDARY Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed). |
2.0; 1.6; 1.8 | <0.001 sig |
| SECONDARY Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed). |
2.4; 2.1; 2.3 | <0.001 sig |
| SECONDARY Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed). |
2.5; 2.4; 2.5 | <0.001 sig |
| SECONDARY Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed). |
63; 43; 106; 30; 52; 82 | 0.002 sig |
| SECONDARY Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed). |
75; 64; 139; 14; 27; 41 | 0.033 sig |
| SECONDARY Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed). |
77; 71; 148; 8; 16; 24 | 0.123 |
| SECONDARY Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF. |
83; 75; 158; 12; 21; 33 | 0.125 |
| SECONDARY Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint |
30.2; 26.4; 28.3 | <0.001 sig |
| SECONDARY Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint |
0.8; 2.1; 1.5 | 0.009 sig |
| SECONDARY Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint |
6.7; 7.2; 7.0 | <0.001 sig |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint |
-2.3; -2.2; -2.3 | <0.001 sig |
| SECONDARY Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint |
-1.4; -1.3; -1.3 | <0.001 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00535132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.