Status:
COMPLETED
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
Lead Sponsor:
Janssen-Ortho Inc., Canada
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 fr...
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00246272
Start Date
October 1 2004
End Date
May 1 2006
Last Update
April 27 2010
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