Schizophrenia
Conditions
Brief summary
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.
Interventions
DRUGAripiprazole
Tablets, Oral, 15 mg fixed dose (week 1-5) flexible dose 10-30 mg (week 6-12), once daily, 12 weeks.
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR2 criteria * Out-patients who have been taking Risperidone for minimum 6 weeks who are not optimally controlled and/or experiencing safety/tolerability issues with Risperidone * Men and women, aged 18 - 65 years
Exclusion criteria
* Patients who are at risk for committing suicide * Patients with a diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic symptoms, or organic brain syndromes * Meeting DSM-IV-TR criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening * Treatment-resistant to antipsychotic medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who discontinue because of Adverse Events | Up to 22 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in Clinical Global Impression scale, Investigator Assessment Questionnaire, cognitive functioning and outcome research assessments at endpoint | Up to 22 months |
Countries
Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed