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

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Ortho Inc., Canada
• Treatments: Risperidone

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