None listed
Conditions
Interventions
Aripiprazole Type of group
Aripiprazole (15-30 mg / day) administered orally without consideration of food for eight weeks.
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Inclusion criteria
Inclusion criteria: External patients men and women between the ages of 18 and 75 years presenting a diagnosis of DSM-IV schizophrenia for whom a change in the medication is clinically reasonable or the initiation of antipsychotic treatment is required. This includes patients who have symptoms that are not optimally controlled, patients experiencing tolerability problems or patients recently diagnosed with schizophrenia.
Exclusion criteria
Exclusion criteria: Women using a prohibited method of contraception. Women who are pregnant or breastfeeding. Women with a positive pregnancy test in the selection or prior to the administration of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Criteria for evaluation include the CGI-Improvement scales, the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q, short form), the Medicine Preference Questionnaire (POM), adverse events and test results. from laboratory. Measure:Effectiveness of 8 weeks of treatment with aripiprazole in patients with schizophrenia that are treated in general psychiatric practice. The CGI-Improvement score escalation will evaluate the overall effectiveness of aripiprazole. The effectiveness evaluation will encompass the patient psychopathology including efficacy, safety and tolerability. Timepoints:week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Safety and tolerability will be evaluated during the 8-week Treatment Phase through EA reports, laboratory tests and vital signs. Measure:The safety and tolerability of aripiprazole. Timepoints:week 8 | — |
Countries
Brazil, Mexico, Peru, Puerto Rico
Outcome results
None listed