Schizophrenia or schizoaffective disorder
Conditions
Interventions
Product Name: Abilify
Pharmaceutical Form: Tablet
INN or Proposed INN: Aripiprazole
Current Sponsor code: OPC-14597
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with a diagnosis of schizophrenia or schizoaffective disorder as defined by DSM-IV-TR criteria who are being managed as outpatients [Hospitalization of patients will be allowed for non medical reasons only (e.g. social reasons, local policy). Patients requiring hospitalization for medical reasons (whether or not related to schizophrenia or schizoaffective disorder) will be excluded from the trial] and have symptoms which in the clinical judgment of the treating psychiatrist require treatment with antipsychotic medication; Patients whose symptoms are not optimally controlled defined as CGI-S =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who are at risk for committing suicide: either having active suicidal ideation considered clinically significant or recently attempted suicide; Patients with a diagnosis of mood disorders, mental disorder due to general medical condition, delirium, dementia and amnestic and other cognitive disorder; Patients who have met DSM-IV-TR criteria for any significant psychoactive substance use disorder within the 3 months prior to Screening; Patients considered treatment-resistant to antipsychotic medication (patients need to have shown a previous response to a antipsychotic medication other than clozapine) and patients with a significant history of intolerance to multiple antipsychotic treatments; Treatment with a long-acting antipsychotic (i.e. haloperidol decanoate, fluphenazine decanoate, etc.) in which the last dose was within 3 months of treatment phase;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effectiveness of eight weeks of treatment with aripiprazole in patients diagnosed with schizophrenia or schizoaffective disorder who are treated in an outpatient psychiatric setting. The overall effectiveness of aripiprazole will be evaluated by use of the CGI-I scale. The evaluation of effectiveness will encompass the patients’ psychopathology, including efficacy, safety and tolerability.;Secondary Objective: The effectiveness of aripiprazole will be further assessed by evaluating: The Clinical Global Impression - Severity of Illness (CGI-S) score; The BPRS Total score; Investigator’s assessment Questionnaire (IAQ); Quality of Life Enjoyment and Satisfaction Questionnaire (assessed by the Q-LES-Q scale); Patients’ and caregivers’ medication preference (assessed by the POM questionnaire); The safety and tolerability of aripiprazole. ;Primary end point(s): The primary effectiveness analysis will be a comparison of the upper bound of the 95% confidence interval (CI) for the mean score of aripiprazole patients on the CGI-I at Week 8 to a score of 4 (no change). | — |
Countries
Czech Republic, Hungary, Lithuania, Slovakia
Outcome results
None listed