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

April 26, 2010 updated by: Janssen-Ortho Inc., Canada

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
CGI-Severity (CGI-S) score for maintenance of clinical effect

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Ortho Inc., Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

October 28, 2005

First Submitted That Met QC Criteria

October 28, 2005

First Posted (Estimate)

October 30, 2005

Study Record Updates

Last Update Posted (Estimate)

April 27, 2010

Last Update Submitted That Met QC Criteria

April 26, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005956

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on risperidone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe