A Prospective, Multicenter, Open-Label Study of Aripiprazole in the Management ofPatients with Schizophrenia in General Psychiatric Practices - ALFA

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 384

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 < 7 and/or whose antipsychotic medication is not well-tolerated defined as clinically significant EPS verified by SAS and/or verified hyperprolactinemia defined as prolactin level above the upper limit of normal (ULN) and/or weight gain defined as increase of BMI by 5% during the previous treatment, which in the clinical judgment of the treating psychiatrist require a change of treatment or initiation of treatment with antipsychotic medication;

Patients who have received adequate treatment with antipsychotics in the past must have shown a response to a neuroleptic medication other than clozapine;

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

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;

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

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