Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246272
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2005-10-28
Brief Title:
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
Sponsor:
Janssen-Ortho Inc Canada
Organization:
Janssen-Ortho Inc Canada
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the maintenance of clinical effect of a rapidly-dissolving tablet form of risperidone an antipsychotic medication in adult schizophrenia patients switched from their previous equivalent dose of RISPERDAL tablets
Detailed Description:
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 05 mg 1 mg 2 mg 3 mg or 4 mgday 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 escalationreduction 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 clinicians assessment of anxiety symptoms and the other measuring clinicians 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 05 1 2 3 or 4 mgday for at least 2 weeks will be switched to an equivalent dose of rapidly-dissolving risperidone tablets 05 1 2 3 or 4 mgday 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
Subjects who are stable on conventional risperidone tablets 05 1 2 3 or 4 mgday for at least 2 weeks will be switched to an equivalent dose of rapidly-dissolving risperidone tablets 05 1 2 3 or 4 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None