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

NCT00246272 | Completed Phase 3

• 1 other identifier: CR005956
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

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

Conditions

Schizophrenia

Keywords

risperidone; schizophrenia; rapidly-dissolving

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• 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.

Interventions

risperidone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Ortho Inc., Canada: lead

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen-Ortho Inc. Clinical Trial

  Janssen-Ortho Inc., Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 28, 2005
• First Posted: October 31, 2005
• Study Start: October 1, 2004
• Study Completion: May 1, 2006
• Last Updated: April 27, 2010

Record last verified: 2010-04