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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

This study has been completed.
Information provided by:
Janssen-Ortho Inc., Canada Identifier:
First received: October 28, 2005
Last updated: April 26, 2010
Last verified: April 2010
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

Condition Intervention Phase
Schizophrenia Drug: risperidone Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:

Further study details as provided by Janssen-Ortho Inc., Canada:

Primary Outcome Measures:
  • CGI-Severity (CGI-S) score for maintenance of clinical effect

Secondary Outcome Measures:
  • 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.

Enrollment: 82
Study Start Date: October 2004
Study Completion Date: May 2006
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00246272

Sponsors and Collaborators
Janssen-Ortho Inc., Canada
Study Director: Janssen-Ortho Inc. Clinical Trial Janssen-Ortho Inc., Canada
  More Information Identifier: NCT00246272     History of Changes
Other Study ID Numbers: CR005956
Study First Received: October 28, 2005
Last Updated: April 26, 2010

Keywords provided by Janssen-Ortho Inc., Canada:

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents processed this record on September 21, 2017