A comparative, randomized, open label, multicenter study on the efficacy and safety of switch treatment with aripiprazole in schizophrenic out-patient who are experiencing insufficient efficacy with risperidone and/or safety and tolerability issues, while on risperidone.
- Conditions
- SchizophreniaMedDRA version: 9.1Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disorders
- Registration Number
- EUCTR2005-000472-40-IT
- Lead Sponsor
- BRISTOL-M.SQUIBB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Signed written informed consent
1) Patients must be competent to understand the nature of the study, sign the informed
consent, agree to comply with prescribed dosage regimens, report for regularly
scheduled visits with their caring physician, able to provide reliable information for
safety, efficacy and Quality of life assessments and communicate to the psychiatrist
about adverse events and concomitant medication use (see Section 10.2.2);
2) The informed consent process must be documented by signing the informed consent
form prior to any study-related procedures including alteration in medications in
preparation for study entry;
Target population
3) Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR2 criteria
(Appendix 2)
4) Out-patients having symptoms which in the clinical judgment of the treating
psychiatrist require treatment with antipsychotic (AP) medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Sex and Reproductive Status
1) WOCBP who are unwilling or unable to use an acceptable method to avoid
pregnancy for the entire study period and for up to 4 weeks after the study.
2) WOCBP using a prohibited contraceptive method. No specific contraceptive
methods are prohibited in this study. Women practicing abstinence should use a
reliable method of contraception (except birth control pills, See Section 5.1) if they
choose to become sexually active during the study.
3) Women who are pregnant or breastfeeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method