An Open-label Study Evaluating the Maintenance of Clinical Effect in Adult Schizophrenia Patients Switched From Risperidone Tablets to an Equivalent Dose of a Rapidly-dissolving Tablet Formulation of Risperdone
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Study Evaluating the Maintenance of Clinical Effect in Adults With Schizophrenia Switched From RISPERDAL® Tablets (Risperidone) to an Equivalent Dose of a Rapidly-dissolving Tablet Formulation of Risperdone|
- CGI-Severity (CGI-S) score for maintenance of clinical effect
- Separate 5-point Likert scales for clinician's assessment of (1) anxiety, (2) depressive, and (3) psychotic symptoms. Visual Analogue Scale (VAS) measurements for patient/caregiver acceptability of rapidly-dissolving risperidone will be summarized.
|Study Start Date:||October 2004|
|Study Completion Date:||May 2006|
This trial is a non-randomized, open-label, single arm, multicentre study aimed at evaluating the maintenance of clinical effect of the rapidly-dissolving tablet dosage form of risperidone, in patients switched from their previous equivalent dose of conventional risperidone tablets (doses of 0.5 mg, 1 mg, 2 mg, 3 mg or 4 mg/day). Approximately 100 adult schizophrenia patients (ages >= 18 years) who are symptomatically stable will be enrolled. Patients will be asked to take an equivalent dose of the rapidly-dissolving tablet form of risperidone for 4 weeks of treatment. Other psychotropic medications taken at study entry may be continued throughout the study, providing the dose was stable prior to entry for a minimum of 4 weeks and will remain stable throughout the course of the study. Dose escalation/reduction of rapidly-dissolving risperidone tablets is not permitted. Study visits will take place twice over the 4 week period, once at study entry and again at the final visit. The primary efficacy parameter will be the CGI-Severity (CGI-S) score for maintenance of clinical effect. Secondarily, two 5-point Likert scales will be completed, one measuring clinician's assessment of anxiety symptoms and the other measuring clinician's assessment of depressive symptoms. Patients with existing symptoms of psychosis will be clinician rated on a 5-point Likert scale. Other secondary assessments include: Visual Analogue Scale (VAS) for risperidone acceptability, completed by the patient or the caregiver (if applicable). For each subject, the VAS score will be calculated on a 10 cm line ranging from a score of "0" (not acceptable) to "10" (very acceptable). Safety evaluations during the study will include vital signs and physical examination, body weight, adverse event surveillance, and urine pregnancy tests for females of childbearing potential. The study hypothesis is that the clinical effect will be maintained when schizophrenia patients previously stabilized on risperidone conventional tablets are treated with rapidly-dissolving risperidone tablets, and that risperidone rapidly dissolving tablets will be well tolerated.
Subjects who are stable on conventional risperidone tablets (0.5, 1, 2, 3 or 4 mg/day) for at least 2 weeks will be switched to an equivalent dose of rapidly-dissolving risperidone tablets (0.5, 1, 2, 3 or 4 mg/day). The study medication will be taken orally for 4 weeks, using the same frequency of dosing (once-daily, twice-daily, etc.) as with their previous conventional tablet regimen.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246272
|Study Director:||Janssen-Ortho Inc. Clinical Trial||Janssen-Ortho Inc., Canada|