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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00535132
• Date of registration: 24/09/2007
• Prospective Registration: Yes
• Primary sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Public title: Study to Measure Drug Satisfaction of Patients With Schizophrenia After Switching From Risperidone to Paliperidone
• Scientific title: A Blinded-initiation Study of Medication Satisfaction in Subjects With Schizophrenia Treated With Paliperidone ER After Suboptimal Response to Oral Risperidone
• Date of first enrolment: October 2007
• Target sample size: 201
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00535132
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Argentina, Colombia, Costa Rica, Czech Republic, Slovakia, Ukraine, United States

Contacts

• Name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
• Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Oral Risperidone

Drug: Paliperidone ER

Primary Outcome(s)

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)]

Secondary Outcome(s)

Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 6 (Observed). [Time Frame: Change from Baseline in MSQ Score at Week 6]

Short Form-36 Health Survey (SF-36) Mental Health Composite Score Change From Baseline to the Week 6 Endpoint [Time Frame: Change from Baseline to Week 6 LOCF]

Modified COVI Anxiety Scale (m-COVI) Change From Baseline to the Week 6 Endpoint [Time Frame: Change from Baseline to Week 6 LOCF]

Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 LOCF. [Time Frame: Week 6 LOCF]

Pittsburgh Sleep Quality Index (PSQI) Change From Baseline to the Week 6 Endpoint [Time Frame: Change from Baseline to Week 6 LOCF]

Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 2 (Observed). [Time Frame: Week 2]

Short Form-36 Health Survey (SF-36) Physical Health Composite Score Change From Baseline to the Week 6 Endpoint [Time Frame: Change from Baseline to Week 6 LOCF]

Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 6 (Observed). [Time Frame: Week 6]

Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 2 (Observed). [Time Frame: Change from Baseline in MSQ Score at Week 2]

Medication Satisfaction Questionnaire (MSQ) Score Change From Baseline to Week 4 (Observed). [Time Frame: Change from Baseline in MSQ Score at Week 4]

Medication Satisfaction Questionnaire (MSQ) - Categorical Summary - Dichotomized Categories - Week 4 (Observed). [Time Frame: Week 4]

Treatment Satisfaction Questionnaire for Medication (TSQM) Global Satisfaction Score Change From Baseline to the Week 6 Endpoint [Time Frame: Change from Baseline to Week 6 LOCF]

Secondary ID(s)

CR014347

R076477SCH4013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/10/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00535132