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Sponsors and Collaborators: |
Bristol-Myers Squibb Otsuka America Pharmaceutical |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00232687 |
The purpose of this clinical research study is to evaluate the safety and tolerability of two switching strategies from risperidone to aripiprazole over a period of 12 weeks in out-patients who are treated in a general psychiatric practice setting and who are currently experiencing efficacy and/or safety/tolerability issues while on risperidone.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: Aripiprazole |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparative, Randomized, Open-Label, Multicenter Study on the Efficacy and Safety of Switch Treatment With Aripiprazole in Schizophrenic Out-Patients Who Are Experiencing Insufficient Efficacy With Risperidone and/or Safety and Tolerability Issues, While on Risperidone |
Estimated Enrollment: | 450 |
Study Start Date: | June 2005 |
Arms | Assigned Interventions |
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A1: Active Comparator |
Drug: Aripiprazole
Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks.
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A2: Active Comparator |
Drug: Aripiprazole
Tablets, Oral, Uptitration: 5 mg (week 1), 10 mg (week 2 and 3), 15 mg(week 4 and 5) flexible 10-30mg from week 6-12, once daily, 12 weeks.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Study ID Numbers: | CN138-169 |
Study First Received: | October 3, 2005 |
Last Updated: | June 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00232687 History of Changes |
Health Authority: | Belgium: Service Public Fédéral Santé Publique, Sécurité de la Chaîne Alimentaire et Environnement |
Schizophrenia Tranquilizing Agents Mental Disorders Psychotropic Drugs Risperidone |
Central Nervous System Depressants Psychotic Disorders Aripiprazole Antipsychotic Agents Schizophrenia and Disorders with Psychotic Features |
Schizophrenia Tranquilizing Agents Mental Disorders Therapeutic Uses Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Depressants Aripiprazole Antipsychotic Agents Central Nervous System Agents Pharmacologic Actions Schizophrenia and Disorders with Psychotic Features |