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
Information source: Janssen-Ortho Inc., Canada
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Condition(s) targeted: Schizophrenia
Intervention: risperidone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Janssen-Ortho Inc., Canada Official(s) and/or principal investigator(s): Janssen-Ortho Inc. Clinical Trial, Study Director, Affiliation: Janssen-Ortho Inc., Canada
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
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: CGI-Severity (CGI-S) score for maintenance of clinical effect
Secondary outcome: 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.
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Baseline CGI-Severity score of either "1" (not ill), "2" (very mildly ill), or "3"
(mildly ill)
- Must have been on a stable dose of conventional risperdone tablets (doses of 0. 5, 1,
2, 3 or 4 mg/day) to treat their disorder for a minimum of 2 weeks
- Patients must be able to comply with the study visit schedule and the patient (or a
caregiver having frequent contact with the patient) must be able to complete the
protocol specified assessments and trial questionnaires
- Females must be postmenopausal, surgically sterile, or practicing an effective method
of birth control, and must have a negative urine pregnancy test pre-study and at the
final visit
- Patient is otherwise healthy on the basis of a pre-trial physical examination and
medical history
Exclusion Criteria:
- Patients who cannot take aspartame (an artificial sweetener that is a source of
phenylalanine)
- Currently taking carbamazepine
- Have a history of neuroleptic malignant syndrome or other serious or unstable medical
illnesses
- Females who is pregnant or breastfeeding
- Patients who have used an experimental drug or an experimental medical device within
30 days before the start of the trial
Locations and Contacts
Additional Information
Starting date: October 2004
Last updated: April 26, 2010
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