Evaluation of the Strategies of Switching Schizophrenia Patients to Aripiprazole From Other Antipsychotic Agents

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether moderately ill Asian schizophrenic patients can be switched from their previous antipsychotic medication to aripiprazole with minimal adverse clinical consequences, and elucidate both pharmacokinetic and pharmacodynamic factors associated with clinical efficacy of aripiprazole.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Collaborators: National Science Council, Taiwan; Taoyuan Psychiatric Center, Ministry of Health and Welfare, Executive Yuan, R.O.C. Taiwan
• Treatments: Antipsychotic Agents; Aripiprazole

Criteria

Inclusion Criteria:

• Men and non-lactating, non-pregnant women who are aged 18 to 65 years

• primary diagnosis of DSM-IV schizophrenia or schizoaffective disorder

• taking a stabilized dose of a single oral antipsychotic for at least 1 month prior to study entry

• cannot have been hospitalized for an exacerbation of schizophrenia or schizoaffective disorder for at least 2 months

Exclusion Criteria:

• having other psychiatric disorders

• hospitalizing for acute exacerbation of patients' condition within 2 months

• having taken a selective serotonin reuptake inhibitor (SSRI) within 4 weeks of screening

• a first episode of schizophrenia or schizoaffective disorder

• a clinically significant neurological abnormality other than tardive dyskinesia or EPS

• current diagnosis of psychoactive substance dependence or a historical drug or alcohol abuse within 1 month before the beginning of the study

• treatment with an investigational drug within 4 weeks prior to randomization

• requiring to take medication that inhibits the microsomal enzyme CYP2D6 or inhibits or acts as a substrate for CYP3A4